Trial Outcomes & Findings for Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery (NCT NCT01396525)

Last Updated: 2016-02-08

Results Overview

Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

153 participants

Primary outcome timeframe

9 months

Results posted on

2016-02-08

Participant Flow

Subjects with chronic lower extremity peripheral arterial disease (PAD) admitted for percutaneous CIA or EIA revascularization were screened for eligibility. Subjects who met all general and clinical eligibility criteria, and signed the informed consent, underwent arteriography of the target iliac artery.

Participant milestones

Participant milestones
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Overall Study STARTED	153
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Overall Study Withdrawal by Subject	8
Overall Study Death	14
Overall Study Lost to Follow-up	4

Baseline Characteristics

Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=93 Participants
Age, Categorical >=65 years	66 Participants n=93 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 9.0 • n=93 Participants
Sex: Female, Male Female	65 Participants n=93 Participants
Sex: Female, Male Male	88 Participants n=93 Participants
Region of Enrollment United States	153 participants n=93 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=149 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Major Adverse Event (MAE)	5.4 percentage of participants Interval to 9.5 One-sided 95% confidence interval was computed for this endpoint, lower bound is not provided.	—	—

SECONDARY outcome

Timeframe: Acute: from beginning of index procedure to end of procedure

Population: ITT population, per device analysis. Included 210 stents plus 1 stent inserted but not implanted due to device malfunction, 2 stents excluded due to inappropriate sizing (stents were not implanted), 1 stent excluded as stent was not implanted per physician's choice and had no device malfunction.

On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=211 devices Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Device Success	98.6 percentage of devices Interval 95.9 to 99.7	—	—

SECONDARY outcome

Timeframe: Acute: from beginning of index procedure to end of procedure

Population: ITT population, per lesion analysis

Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of \< 30% by QA or as reported by the investigator.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 target lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Technical Success	93.1 percentage of target lesions Interval 88.7 to 96.2	—	—

SECONDARY outcome

Timeframe: Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner

Population: ITT population, per subject analysis

Procedure success is defined as technical success (device success and attainment of a final residual stenosis of \< 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Procedure Success	91.5 percentage of participants Interval 85.9 to 95.4	—	—

SECONDARY outcome

Timeframe: Pre-procedure

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=189 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Thigh Brachial Index (TBI) for the Treated Limb(s)	0.9 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: Post-Procedure

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=188 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.0 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: 1 month

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=178 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.0 Ratio Standard Deviation 0.1	—	—

SECONDARY outcome

Timeframe: 9 months

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=180 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.0 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=140 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.0 Ratio Standard Deviation 0.1	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=132 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.0 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: Between baseline and Post-procedure

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=179 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.2 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: Between Baseline and 1 month

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=168 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.2 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: Between baseline and 9 months

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=166 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.1 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: Between baseline and 2 years

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=128 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.2 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: Between baseline and 3 years

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=122 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.2 Ratio Standard Deviation 0.2	—	—

SECONDARY outcome

Timeframe: Pre-procedure

Population: ITT population, per subject analysis

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=152 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score n=151 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score n=151 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Walking Impairment Questionaire Scores	17.5 score on a scale Standard Deviation 22.7 • Interval 17.5 to 22.7	20.1 score on a scale Standard Deviation 24.0	26.0 score on a scale Standard Deviation 25.8

SECONDARY outcome

Timeframe: 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=131 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score n=131 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score n=129 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Walking Impairment Questionaire Scores	56.4 score on a scale Standard Deviation 38.0	50.4 score on a scale Standard Deviation 34.4	56.1 score on a scale Standard Deviation 36.7

SECONDARY outcome

Timeframe: 9 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=138 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score n=138 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score n=134 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Walking Impairment Questionaire Scores	56.6 score on a scale Standard Deviation 38.6	47.6 score on a scale Standard Deviation 33.2	60.4 score on a scale Standard Deviation 35.9

SECONDARY outcome

Timeframe: 2 years

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=112 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score n=113 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score n=112 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Walking Impairment Questionaire Scores	49.1 score on a scale Standard Deviation 37.9	44.5 score on a scale Standard Deviation 31.1	51.7 score on a scale Standard Deviation 33.8

SECONDARY outcome

Timeframe: 3 years

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=107 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score n=107 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score n=105 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Walking Impairment Questionaire Scores	46.8 score on a scale Standard Deviation 37.1	41.8 score on a scale Standard Deviation 30.4	55.4 score on a scale Standard Deviation 34.9

SECONDARY outcome

Timeframe: Pre-Procedure

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limb(s) Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Rutherford Becker Clinical Category for the Treated Limb(s) 0	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 1	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 2	43.8 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 3	54.7 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 4	1.5 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 1 month

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=180 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Rutherford Becker Clinical Category for the Treated Limb(s) 2	15.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 3	3.3 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 0	57.8 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 1	23.9 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 9 months

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=182 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Rutherford Becker Clinical Category for the Treated Limb(s) 0	59.9 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 1	23.6 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 2	11.5 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 3	4.4 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.5 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=143 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Rutherford Becker Clinical Category for the Treated Limb(s) 3	2.8 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 0	66.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 1	16.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 2	15.3 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=138 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Rutherford Becker Clinical Category for the Treated Limb(s) 2	15.1 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 0	64.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 1	16.5 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 3	3.6 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 percentage of target limbs	—	—
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.7 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: Between baseline and 1 month

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=180 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	36.1 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	34.4 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	18.9 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No change	8.9 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 1 category	1.7 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 2 categories	0.0 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 3 categories or more	0.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: Between baseline and 9 months

Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=137 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	34.6 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	41.2 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	13.2 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No change	7.1 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 1 category	3.8 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 2 categories	0.0 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 3 categories or more	0.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=143 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	16.7 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	35.4 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	37.5 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No change	9.0 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 1 category	1.4 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 2 categories	0.0 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by >/= 3 categories	0.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: Baseline and 3 years

Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=138 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	38.8 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	33.1 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	15.1 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No Change	11.5 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 1 category	0.7 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by 2 categories	0.0 percentage of target limbs	—	—
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Worsened by >/= 3 categories	0.7 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) 1 month	99.0 percentage of target lesions	—	—
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) 9 months	95.5 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)	93.9 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)	90.5 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)	87.6 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) 1 month	99.5 percentage of target lesions	—	—
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) 9 months	97 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)	95.3 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)	93.1 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)	90.8 percentage of target lesions	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) 1 month	99.0 percentage of target vessels	—	—
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) 9 months	98.5 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)	98.0 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)	97.4 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)	95.6 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) 1 month	99.5 percentage of target vessels	—	—
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) 9 months	99.5 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)	99 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)	98.4 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 Lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)	96.6 percentage of target vessels	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) 1 month	99.5 percentage of limbs	—	—
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) 9 months	98.0 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)	95.8 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)	94.1 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)	94.1 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 1 month

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=188 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Primary Stent Patency	97.3 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 9 months

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=179 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Primary Stent Patency	89.9 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=163 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Primary Stent Patency	76.7 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=155 Limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Primary Stent Patency	68.4 percentage of limbs	—	—

SECONDARY outcome

Timeframe: 9 months

Population: ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as ≥ 50% stenosis at follow-up.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=185 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Restenosis	9.7 percentage of limbs Interval 5.9 to 14.9	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as ≥ 50% stenosis at follow-up.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=159 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Restenosis	20.8 percentage of limbs Interval 14.7 to 27.9	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as ≥ 50% stenosis at follow-up.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=148 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Restenosis	27.0 percentage of limbs Interval 20.1 to 34.9	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population. This analysis represents those subjects who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Death (All Cause) 1 month	100 percentage of participants	—	—
Kaplan-Meier Estimate of Freedom From Death (All Cause) 9 months	99.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Death (All Cause)	94.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Death (All Cause)	93.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population.This analysis represents those subjects who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Death (All Cause)	90.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population. This analysis represents those subjects who were event free at this timepoint

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) 1 month	100.0 percentage of participants	—	—
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) 9 months	99.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population. This analysis represents those subjects who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)	97.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population.This analysis represents those subjects who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)	95.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population.This analysis represents those subjects who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)	95.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) 1 month	100.0 percentage of target limbs	—	—
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) 9 months	100.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)	100 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)	100 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)	99.4 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population.This analysis represents those subjects who were event free at this timepoint

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Embolic Events 1 month	99.3 percentage of particpants	—	—
Kaplan-Meier Estimate of Freedom From Embolic Events 9 months	98.0 percentage of particpants	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population.This analysis represents those subjects who were event free at this timepoint

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Embolic Events	98 percentage of particpants	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population.This analysis represents those subjects who were event free at this time point.

Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Embolic Events	97.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population.This analysis represents those subjects who were event free at this time point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Embolic Events	96.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 1 month and 9 months

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) 9 months	100.0 percentage of target limbs	—	—
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) 1 month	100.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 18 months

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)	100.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 2 years

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)	100.0 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=203 limbs Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)	99.4 percentage of target limbs	—	—

SECONDARY outcome

Timeframe: 1 month

Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=201 lesions Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Stent Thrombosis	0.5 percentage of target lesions Interval 0.0 to 2.7	—	—

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=132 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Physical Component Summary	10.4 score on a scale Standard Deviation 11.3	—	—

SECONDARY outcome

Timeframe: Baseline and 9 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=136 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Physical Component Summary	9.8 score on a scale Standard Deviation 11.5	—	—

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=112 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Physical Component Summary	8.2 score on a scale Standard Deviation 12.7	—	—

SECONDARY outcome

Timeframe: Baseline and 3 years

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=108 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Physical Component Summary	8.9 score on a scale Standard Deviation 13.7	—	—

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=132 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Mental Component Summary	2.3 score on a scale Standard Deviation 10.7	—	—

SECONDARY outcome

Timeframe: Baseline and 9 months

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=136 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Mental Component Summary	0.9 score on a scale Standard Deviation 11.7	—	—

SECONDARY outcome

Timeframe: Baseline and 2 years

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=112 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Mental Component Summary	2.2 score on a scale Standard Deviation 12.1	—	—

SECONDARY outcome

Timeframe: Baseline and 3 years

Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measures

Outcome measures
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=108 Participants Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Walking Speed Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).	Stair Climbing Score Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Changes in Quality of Life Measures: Mental Component Summary	-0.5 score on a scale Standard Deviation 13.4	—	—

Adverse Events

Omnilink Elite™ Peripheral Balloon-Expandable Stent System

Serious events: 94 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 participants at risk Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Injury, poisoning and procedural complications Hematoma	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Injury, poisoning and procedural complications Pseudoaneurysm	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Blood and lymphatic system disorders Anemia	5.9% 9/153 • Number of events 10 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	6.5% 10/153 • Number of events 11 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Angina	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Arrhythmias (other than bradycardia)	4.6% 7/153 • Number of events 8 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Cardiac / Hemodynamic	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Cardiac Arrest	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Congestive Heart Failure	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Myocardial Infarction - Non-Q- wave	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Myocardial Infarction - Q- wave	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Other: Arrhythmia	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Other: Chest Pain	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Other: Coronary Artery Disease	7.2% 11/153 • Number of events 11 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Pain	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Bradycardia	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Hypertension	2.0% 3/153 • Number of events 6 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Hypotension	2.6% 4/153 • Number of events 4 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Pulmonary Edema	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Syncope	2.0% 3/153 • Number of events 3 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Diarrhea	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders GI Bleed	4.6% 7/153 • Number of events 7 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Gastro-intestinal	2.6% 4/153 • Number of events 5 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Infection	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Nausea	2.0% 3/153 • Number of events 4 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Abdominal Pain	0.65% 1/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Cholecystitis	2.0% 3/153 • Number of events 3 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Cholelithiasis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Dehydration	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Diabetic Gastroparesis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Duodenal Ulcer	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Incisional Hernia	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Other: Pancreatitis	0.65% 1/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Pain	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Gastrointestinal disorders Surgery/Interventional Procedure	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Gastro-intestinal	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Infection	0.65% 1/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Other: Abscess	0.65% 1/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Other: Bronchitis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Other: Cellulitis	2.0% 3/153 • Number of events 4 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Pneumonia	9.2% 14/153 • Number of events 21 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Respiratory	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Sepsis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Infections and infestations Wound complication or wound infection	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Metabolism and nutrition disorders Other: Acidosis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Metabolism and nutrition disorders Other: Fatigue	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Metabolism and nutrition disorders Other: Hypocalcemia	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Metabolism and nutrition disorders Other: Hypokalemia	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Metabolism and nutrition disorders Other: Hyponatremia	1.3% 2/153 • Number of events 5 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Edema (non pulmonary)	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Genito-urinary	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Musculoskeletal and connective tissue disorders Musculoskeletal	10.5% 16/153 • Number of events 17 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Other	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Other: Acquired Spondylolistheses	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Other: Frequent Falls	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Other: Lethargy	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Other: Multi Organ Failure	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Other: Shingles	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Other: Trauma	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Surgery/Interventional Procedure	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Myocardial Infarction - Unknown	2.0% 3/153 • Number of events 3 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Other: Myocardial Infarction - Non-Q Wave	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Nervous system disorders Mental Status Change	2.0% 3/153 • Number of events 4 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Nervous system disorders Other: Anoxic Injury	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Nervous system disorders Seizure	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Nervous system disorders Transient Ischemic Attack	2.6% 4/153 • Number of events 4 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Nervous system disorders Vision disturbance	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Injury, poisoning and procedural complications Bleeding	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Musculoskeletal and connective tissue disorders Hematoma	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Injury, poisoning and procedural complications Dissection	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Injury, poisoning and procedural complications Distal Emboli	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	5.9% 9/153 • Number of events 16 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Embolism	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Infection	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Other: Pleural Effusion	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Renal and urinary disorders Renal Failure	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Renal and urinary disorders Renal Insufficiency	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Other: Acute Exacerbation Asthma	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Other: Atelectasis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Other: Dyspnea	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Other: Shortness Of Breath	2.6% 4/153 • Number of events 6 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	5.9% 9/153 • Number of events 13 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Viral, bacterial and fungal infections	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: CVA	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Cerebral Vascular Accident	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Lacunar Stroke	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Stroke	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Dissection	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Gastro-intestinal	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Ischemia	1.3% 2/153 • Number of events 4 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Occlusion	3.3% 5/153 • Number of events 7 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Aortic Iliac	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Carotid Artery Disease	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Deep Vein Thrombosis	2.0% 3/153 • Number of events 3 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Peripheral Vascular Disease	6.5% 10/153 • Number of events 12 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Stenosis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Pain	0.65% 1/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Pulmonary Embolism	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Renal	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Restenosis	9.2% 14/153 • Number of events 16 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Stenosis	16.3% 25/153 • Number of events 44 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Stent Thrombosis	0.65% 1/153 • Number of events 1 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Surgery/Interventional Procedure	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Thrombosis	1.3% 2/153 • Number of events 2 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.

Other adverse events

Other adverse events
Measure	Omnilink Elite™ Peripheral Balloon-Expandable Stent System n=153 participants at risk Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Blood and lymphatic system disorders Anemia	5.2% 8/153 • Number of events 9 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Cardiac disorders Hypertension	5.2% 8/153 • Number of events 9 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
General disorders Edema (non pulmonary)	8.5% 13/153 • Number of events 15 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Musculoskeletal and connective tissue disorders Musculoskeletal	31.4% 48/153 • Number of events 78 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Respiratory, thoracic and mediastinal disorders Other: Shortness Of Breath	5.2% 8/153 • Number of events 8 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Other: Peripheral Vascular Disease	13.7% 21/153 • Number of events 23 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.
Vascular disorders Stenosis	11.1% 17/153 • Number of events 17 • 3 years Designations were chosen to match Abbott Categories coding and may differ from other coding systems. Denominators for event rates excludes: lost to follow-up, withdrew through 3 years without adverse events (AE). Entries in the AE category column were coded using trial specific in-house coding classification.

Additional Information

David R Rutledge

AbbottVascular

Phone: 408-845-3820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60