Trial Outcomes & Findings for Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery. (NCT NCT00844532)

Last Updated: 2015-06-09

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

151 participants

Primary outcome timeframe

9 months

Results posted on

2015-06-09

Participant Flow

Trial population is comprised of male and female subjects with moderate to severe iliac artery atherosclerotic occlusive disease. Recruitment dates: March 23, 2009 through May 17, 2010

Participant milestones

Participant milestones
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Overall Study STARTED	151
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Overall Study Death	16
Overall Study Withdrawal by Subject	16
Overall Study Lost to Follow-up	7

Baseline Characteristics

Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants
Age, Categorical >=65 years	66 Participants n=5 Participants
Age, Continuous	62.8 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants
Region of Enrollment United States	151 participants n=5 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=147 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Major Adverse Event (MAE) Rate	6.1 percentage of participants Interval to 10.4 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 index procedure.

Population: Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=193 devices The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Device Success	96.4 percentage of devices Interval 92.7 to 98.5

SECONDARY outcome

Timeframe: acute: from beginning of index procedure to end of index procedure.

Population: ITT population

Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of \< 30% by QA or as reported by the investigator, if QA is not available.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 target lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Technical Success	87.3 percentage of target lesions Interval 81.5 to 91.8

SECONDARY outcome

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

Population: ITT population

Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Procedure Success	85.4 percentage of participants Interval 78.8 to 90.6

SECONDARY outcome

Timeframe: Pre-procedure

Population: Per target limb analysis. ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=170 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Thigh Brachial Index (TBI) for the Treated Limb(s)	0.8 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: Post-procedure

Population: Per target limb analysis. ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=162 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.0 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: 1 month

Population: Per target limb analysis.ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.1 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: 9 months

Population: Per target limb analysis. ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=144 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.1 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: 2 years

Population: Per target limb analysis. ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=118 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.0 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: 3 years

Population: Per target limb analysis. ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=109 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Thigh Brachial Index (TBI) for the Treated Limb(s)	1.1 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: Post-procedure

Population: ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=160 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.2 Ratio Standard Deviation 0.2

SECONDARY outcome

Timeframe: 1 month

Population: ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=145 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.3 Ratio Standard Deviation 0.3

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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=136 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.3 Ratio Standard Deviation 0.2

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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=112 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.2 Ratio Standard Deviation 0.2

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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=102 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	0.2 Ratio Standard Deviation 0.3

SECONDARY outcome

Timeframe: Pre-procedure

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

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).

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Walking Impairment Questionaire Scores Walking Distance Score	14.0 score on a scale Standard Deviation 19.9
Walking Impairment Questionaire Scores Walking Speed Score	17.9 score on a scale Standard Deviation 20.8
Walking Impairment Questionaire Scores Stair Climbing Score	22.7 score on a scale Standard Deviation 23.9

SECONDARY outcome

Timeframe: 1 month

Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=135 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Walking Impairment Questionaire Scores Stair Climbing Score (N=127)	55.9 scores on a scale Standard Deviation 36.7
Walking Impairment Questionaire Scores Walking Distance Score (N=134)	53.8 scores on a scale Standard Deviation 37.6
Walking Impairment Questionaire Scores Walking Speed Score (N=135)	51.8 scores on a scale Standard Deviation 33.5

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. The highest 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=127 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Walking Impairment Questionaire Scores Walking Distance Score (N=127)	55.7 scores on a scale Standard Deviation 39.6
Walking Impairment Questionaire Scores Walking Speed Score (N=126)	50.6 scores on a scale Standard Deviation 33.9
Walking Impairment Questionaire Scores Stair Climbing Score (N=119)	59.2 scores on a scale Standard Deviation 37.5

SECONDARY outcome

Timeframe: 2 years

Measured by the Walking Impairment Questionnaire (WIQ)

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=99 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Walking Impairment Questionaire Scores Walking Distance Score (N=99)	58.2 scores on a scale Standard Deviation 37.1
Walking Impairment Questionaire Scores Walking Speed Score (N=99)	50.6 scores on a scale Standard Deviation 32.4
Walking Impairment Questionaire Scores Stair Climbing Score (N=95)	59.1 scores on a scale Standard Deviation 36.0

SECONDARY outcome

Timeframe: 3 years

Measured by the Walking Impairment Questionnaire (WIQ)

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=94 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Walking Impairment Questionaire Scores Walking Distance Score (N=94)	54.1 scores on a scale Standard Deviation 40.0
Walking Impairment Questionaire Scores Walking Speed Score (N=94)	49.2 scores on a scale Standard Deviation 33.0
Walking Impairment Questionaire Scores Stair Climbing Score (N=88)	58.9 scores on a scale Standard Deviation 37.2

SECONDARY outcome

Timeframe: Pre-Procedure

Population: ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Rutherford Becker Clinical Category for the Treated Limb(s) 1	0.6 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 2	28.2 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 3	63.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 4	8.3 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 0	0.0 Percentage of Limbs

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=161 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Rutherford Becker Clinical Category for the Treated Limb(s) 2	15.5 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 3	2.5 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.6 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 0	54.7 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 1	26.7 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.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=148 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Rutherford Becker Clinical Category for the Treated Limb(s) 1	23.6 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 2	14.2 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 3	2.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 0	60.1 Percentage of Limbs

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.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=119 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Rutherford Becker Clinical Category for the Treated Limb(s) 0	61.2 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 1	25.6 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 2	7.4 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 3	4.1 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 5	1.7 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 Percentage of Limbs

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.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=113 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Rutherford Becker Clinical Category for the Treated Limb(s) 0	69.9 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 1	18.6 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 2	9.7 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 3	1.8 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 4	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 5	0.0 Percentage of Limbs
Rutherford Becker Clinical Category for the Treated Limb(s) 6	0.0 Percentage of Limbs

SECONDARY outcome

Timeframe: Between baseline and 1 month

Population: ITT population.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	Absolute Pro™ Peripheral Self-Expanding Stent System n=161 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	30.4 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	18.6 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No change	8.1 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	42.2 Percentage of Limbs

SECONDARY outcome

Timeframe: Between baseline and 9 months

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=148 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	17.6 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No change	6.1 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	29.1 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	47.3 Percentage of Limbs

SECONDARY outcome

Timeframe: Between baseline and 2 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=119 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	52.9 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	19.8 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	21.5 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No change	3.3 Percentage of Limbs

SECONDARY outcome

Timeframe: Between baseline and 3 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=113 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by >/= 3 categories	56.6 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 2 categories	23.0 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) Improved by 1 category	15.0 Percentage of Limbs
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) No change	5.3 Percentage of 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.

Target lesion revascularization was 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) 1 month	100 percentage of target lesions
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) 9 months	95.6 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 timepoint.

Target lesion revascularization was 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)	93.5 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 timepoint.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesion The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)	89.6 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 timepoint.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)	84.4 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) 1 month	100 percentage of target lesions
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) 9 months	97.1 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 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 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)	94.7 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 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 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)	91.4 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 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 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)	86.9 percentage of target lesions

SECONDARY outcome

Timeframe: 1 month and 9 months

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

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) 1 month	100 percentage of target vessels
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) 9 months	96.5 percentage of target vessels

SECONDARY outcome

Timeframe: 18 months

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)	96.5 percentage of target vessels

SECONDARY outcome

Timeframe: 2 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)	94.5 percentage of target vessels

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)	92.2 percentage of target vessels

SECONDARY outcome

Timeframe: 1 month and 9 months

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

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) 1 month	100 percentage of target vessels
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) 9 months	97.1 percentage of target vessels

SECONDARY outcome

Timeframe: 18 months

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)	97.1 percentage of target vessels

SECONDARY outcome

Timeframe: 2 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)	95.1 percentage of target vessels

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Lesions The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)	94.3 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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) 1 month	99.4 percentage of limbs
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) 9 months	97.7 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)	96.6 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)	95.3 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)	93.0 percentage of limbs

SECONDARY outcome

Timeframe: 1 month

Population: ITT population. 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=172 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Primary Stent Patency	98.3 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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=154 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Primary Stent Patency	90.9 percentage of limbs

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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=140 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Primary Stent Patency	80.7 percentage of limbs

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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=125 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Primary Stent Patency	75.2 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=154 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Restenosis	8.4 percentage of limbs Interval 4.6 to 14.0

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=136 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Restenosis	16.9 percentage of limbs Interval 11.0 to 24.3

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=118 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Restenosis	20.3 percentage of limbs Interval 13.5 to 28.7

SECONDARY outcome

Timeframe: 1 month and 9 months

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

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
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	96.1 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 analysed at 1, 9 and 18 months, 2 and 3 years

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
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 analysed at 1, 9 and 18 months, 2 and 3 years

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Death (All Cause)	92.3 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 measure analysed at 1, 9 and 18 months, 2 and 3 years

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Death (All Cause)	88.3 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 time point.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) 1 month	100 percentage of participants
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) 9 months	98.6 percentage of participants

SECONDARY outcome

Timeframe: 18 months

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

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)	97.9 percentage of participants

SECONDARY outcome

Timeframe: 2 years

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

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)	97.1 percentage of participants

SECONDARY outcome

Timeframe: 3 years

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

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)	96.2 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 time point.

Amputation is defined as 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; a major amputation will be defined as at or above the ankle.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) 1 month	100 percentage of limbs
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) 9 months	99.4 percentage of 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 measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)	99.4 percentage of 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)	99.4 percentage of 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=181 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)	99.4 percentage of limbs

SECONDARY outcome

Timeframe: 1 month and 9 months

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

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Embolic Events 9 months	98.7 percentage of participants
Kaplan-Meier Estimate of Freedom From Embolic Events 1 month	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.

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Embolic Events	98.7 percentage of participants

SECONDARY outcome

Timeframe: 2 years

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

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Embolic Events	98.7 percentage of participants

SECONDARY outcome

Timeframe: 3 years

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

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	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Kaplan-Meier Estimate of Freedom From Embolic Events	98.7 percentage of participants

SECONDARY outcome

Timeframe: 1 month

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

Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=177 Limbs The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Stent Thrombosis	0.6 percentage of limbs Interval 0.0 to 3.1

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: ITT population. 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	Absolute Pro™ Peripheral Self-Expanding Stent System n=133 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Physical Component Summary	9.9 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: Baseline and 9 months

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=124 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Physical Component Summary	9.5 scores on a scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=101 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Physical Component Summary	10.0 scores on a scale Standard Deviation 12.9

SECONDARY outcome

Timeframe: Baseline and 3 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=96 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Physical Component Summary	8.9 scores on a scale Standard Deviation 11.6

SECONDARY outcome

Timeframe: Baseline and 1 month

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=133 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Mental Component Summary	3.9 scores on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: Baseline and 9 months

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=124 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Mental Component Summary	1.9 scores on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=101 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Mental Component Summary	2.2 scores on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: Baseline and 3 years

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

Outcome measures

Outcome measures
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=96 Participants The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Changes in Quality of Life Measures: Mental Component Summary	2.7 scores on a scale Standard Deviation 12.4

Adverse Events

Absolute Pro™ Peripheral Self-Expanding Stent System

Serious events: 91 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 participants at risk The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Injury, poisoning and procedural complications Bleeding	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Injury, poisoning and procedural complications Pain at insertion site	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Injury, poisoning and procedural complications Pseudoaneurysm	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Blood and lymphatic system disorders Anemia	5.3% 8/151 • Number of events 9 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Blood and lymphatic system disorders Thrombocytopenia	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	6.0% 9/151 • Number of events 10 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Angina	4.0% 6/151 • Number of events 6 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Arrhythmias (other than bradycardia)	4.6% 7/151 • Number of events 7 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Bradycardia	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Cardiac Arrest	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Congestive Heart Failure	4.0% 6/151 • Number of events 6 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Other: Chest Pain	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Other: Coronary Artery Disease	4.6% 7/151 • Number of events 8 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Pain	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Surgery/Interventional Procedure	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Hypertension	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Hypotension	2.6% 4/151 • Number of events 4 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Syncope	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Abdominal Pain	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Bleeding	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Diarrhea	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Gastrointestinal Bleed	4.0% 6/151 • Number of events 6 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Gastro-intestinal	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Other: Cholecystitis	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Other: Esophagitis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Other: Hernia	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Other: Malnutrition	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Other: Pancreatitis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Gastrointestinal disorders Pain	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Fever	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Gastro-intestinal	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Musculoskeletal	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Other: Cellulitis	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Other: Facial Abscess	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Other: Foot Ulcer	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Other: Inguinal Cellulitis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Other: Osteomyelitis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Other: Pancreatitis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Pneumonia	6.0% 9/151 • Number of events 10 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Sepsis	2.0% 3/151 • Number of events 3 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Urinary Tract Infection	2.0% 3/151 • Number of events 4 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Viral, bacterial and fungal infections	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Infections and infestations Wound complication or wound infection	2.0% 3/151 • Number of events 4 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Metabolism and nutrition disorders Diabetes	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Metabolism and nutrition disorders Other: Hyperglycemia	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Metabolism and nutrition disorders Other: Hypoglycemia	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Genito-urinary	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Headache	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Musculoskeletal	6.0% 9/151 • Number of events 11 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Other: Non Cardiac Chest Pain	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Surgery/Interventional Procedure	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Wound complication or wound infection	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Myocardial Infarction - Non-Q- wave	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Myocardial Infarction - Unknown	2.0% 3/151 • Number of events 3 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Other: Non Stemi MI	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Confusion	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Mental Status Change	1.3% 2/151 • Number of events 3 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Myalgia	0.66% 1/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Other: Hydrocephalus	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Other: Anoxic Encephalopathy	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Other: Anxiety	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Other: Extremity Tremors	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Other: Metabolic Encephalopathy	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Other: Subarachnoid/Intracerebral Hemorrhage	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Seizure	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Surgery/Interventional Procedure	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Nervous system disorders Transient Ischemic Attack	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Injury, poisoning and procedural complications Dissection	2.6% 4/151 • Number of events 4 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Injury, poisoning and procedural complications Hypertension	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	2.6% 4/151 • Number of events 4 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Respiratory, thoracic and mediastinal disorders Other: Pleural Effusion	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Renal and urinary disorders Renal Failure	2.0% 3/151 • Number of events 4 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Respiratory, thoracic and mediastinal disorders Other: Drug Toxicity	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Respiratory, thoracic and mediastinal disorders Other: Dyspnea	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Respiratory, thoracic and mediastinal disorders Other: Shortness Of Breath	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	4.6% 7/151 • Number of events 7 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Other: cerebrovascular accident	1.3% 2/151 • Number of events 3 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Other: Right Cerebellar Infarct	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Stroke: Unknown	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Aneurysm	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Dissection	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Hematoma	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Ischemia	0.66% 1/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Occlusion	6.0% 9/151 • Number of events 11 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Other: Carotid Stenosis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Other: Deep Vein Thrombosis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Other: Peripheral Vascular Disease	9.3% 14/151 • Number of events 25 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Pseudoaneurysm	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Restenosis	4.0% 6/151 • Number of events 12 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Stenosis	13.9% 21/151 • Number of events 31 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Surgery/Interventional Procedure	1.3% 2/151 • Number of events 2 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Thrombosis	0.66% 1/151 • Number of events 1 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.

Other adverse events

Other adverse events
Measure	Absolute Pro™ Peripheral Self-Expanding Stent System n=151 participants at risk The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
Cardiac disorders Arrhythmias (other than bradycardia)	5.3% 8/151 • Number of events 8 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Cardiac disorders Hypotension	6.6% 10/151 • Number of events 11 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Edema (non pulmonary)	5.3% 8/151 • Number of events 9 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Musculoskeletal and connective tissue disorders Musculoskeletal	35.1% 53/151 • Number of events 85 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
General disorders Pain	6.6% 10/151 • Number of events 11 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Other: Peripheral Vascular Disease	13.9% 21/151 • Number of events 26 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.
Vascular disorders Stenosis	7.3% 11/151 • Number of events 12 • 3 years Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.

Additional Information

David R Rutledge

Abbott Vascular

Phone: 408-845-3820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60