Trial Outcomes & Findings for EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries (NCT NCT00896337)
NCT ID: NCT00896337
Last Updated: 2015-05-07
Results Overview
MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months
COMPLETED
PHASE3
125 participants
9 Months
2015-05-07
Participant Flow
Enrollment of up to 133 subjects was planned; 125 subjects were enrolled at 28 centers in the United States from May 14, 2009 to December 14, 2010.
Participant milestones
| Measure |
ORION
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
|
|---|---|
|
Overall Study
STARTED
|
125
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
ORION
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
11
|
Baseline Characteristics
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Baseline characteristics by cohort
| Measure |
ORION
n=125 Participants
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
112 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African heritage
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=5 Participants
|
|
General Medical History
Smoking, Ever
|
121 Participants
n=5 Participants
|
|
General Medical History
Medically Treated Diabetes
|
42 Participants
n=5 Participants
|
|
General Medical History
Hyperlipidemia Requiring Medication
|
98 Participants
n=5 Participants
|
|
General Medical History
Hypertension Requiring Medication
|
95 Participants
n=5 Participants
|
|
General Medical History
History of Chronic Obstructive Pulmonary Disease
|
31 Participants
n=5 Participants
|
|
Cardiac History
History of Coronary Artery Disease
|
73 Participants
n=5 Participants
|
|
Cardiac History
History of Myocardial Infarction
|
36 Participants
n=5 Participants
|
|
Cardiac History
History of Congestive Heart Failure
|
10 Participants
n=5 Participants
|
|
Cardiac History
Stable Angina
|
15 Participants
n=5 Participants
|
|
Cardiac History
Unstable Angina
|
1 Participants
n=5 Participants
|
|
Cardiac History
Silent Ischemia
|
0 Participants
n=5 Participants
|
|
Cardiac History
Previous Percutaneous Coronary Intervention
|
46 Participants
n=5 Participants
|
|
Cardiac History
Previous Coronary Artery Bypass Graft
|
22 Participants
n=5 Participants
|
|
Peripheral Vascular History
History of Peripheral Vascular Surgery
|
10 Participants
n=5 Participants
|
|
Peripheral Vascular History
History of Other Peripheral Endovascular Intervent
|
25 Participants
n=5 Participants
|
|
Peripheral Vascular History
History of Claudication
|
116 Participants
n=5 Participants
|
|
Neurologic/Renal History
History of Transient Ischemic Attack
|
5 participants
n=5 Participants
|
|
Neurologic/Renal History
History of Cerebrovascular Accident
|
7 participants
n=5 Participants
|
|
Neurologic/Renal History
History of Renal Insufficiency
|
9 participants
n=5 Participants
|
|
Neurologic/Renal History
History of Renal Percutaneous Intervention
|
6 participants
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Common Iliac Artery
|
58 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left External Iliac Artery
|
16 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Right Common Iliac Artery
|
58 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Right External Iliac Artery
|
28 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Ostial
|
100 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Proximal
|
35 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Mid
|
12 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Distal
|
13 Lesions
n=5 Participants
|
|
Lesion Characteristics: Size
Reference Vessel Diameter
|
7.69 millimeters
STANDARD_DEVIATION 1.79 • n=5 Participants
|
|
Lesion Characteristics: Size
Minimum Lumen Diameter
|
2.20 millimeters
STANDARD_DEVIATION 1.34 • n=5 Participants
|
|
Lesion Characteristics: Size
Lesion Length
|
31.04 millimeters
STANDARD_DEVIATION 22.13 • n=5 Participants
|
|
Lesion Characteristic: Diameter Stenosis
|
71.51 percent
STANDARD_DEVIATION 16.27 • n=5 Participants
|
|
Lesion Characteristics
Concentric Lesion
|
72 Lesions
n=5 Participants
|
|
Lesion Characteristics
Eccentric Lesion
|
88 Lesions
n=5 Participants
|
|
Lesion Characteristics
> 45 Degree Bend
|
1 Lesions
n=5 Participants
|
|
Lesion Characteristics
> 90 Degree Bend
|
0 Lesions
n=5 Participants
|
|
Lesion Characteristics
Thrombus
|
0 Lesions
n=5 Participants
|
|
Lesion Characteristics
Calcification, Non/Mild
|
37 Lesions
n=5 Participants
|
|
Lesion Characteristics
Calcification, Moderate
|
45 Lesions
n=5 Participants
|
|
Lesion Characteristics
Calcification, Severe
|
78 Lesions
n=5 Participants
|
|
Lesion Characteristics
Ulcerated
|
29 Lesions
n=5 Participants
|
|
Lesion Characteristics
Total Occlusion
|
26 Lesions
n=5 Participants
|
|
Lesion Characteristics
Aneurysm
|
10 Lesions
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months
Outcome measures
| Measure |
Epic Stent
n=118 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Device- and/or Procedure-related Major Adverse Events (MAE)
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Outcome measures
| Measure |
Epic Stent
n=121 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Death
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Outcome measures
| Measure |
Epic Stent
n=118 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Death
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.
Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Outcome measures
| Measure |
Epic Stent
n=114 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Death
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.
Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Outcome measures
| Measure |
Epic Stent
n=108 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Death
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.
Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Outcome measures
| Measure |
Epic Stent
n=107 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Death
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Outcome measures
| Measure |
Epic Stent
n=118 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Amputation of Index Limb
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Outcome measures
| Measure |
Epic Stent
n=112 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Amputation of Index Limb
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Outcome measures
| Measure |
Epic Stent
n=106 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Amputation of Index Limb
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Outcome measures
| Measure |
Epic Stent
n=100 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Amputation of Index Limb
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=121 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=118 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=112 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=106 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=101 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Vessel Revascularization (TVR)
|
12.9 percentage of participants
|
SECONDARY outcome
Timeframe: Index hospitalizationPopulation: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels \>2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels \>2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK \>2× ULN will be considered an MI. ULN is determined per local laboratory specifications.
Outcome measures
| Measure |
Epic Stent
n=125 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Myocardial Infarction (MI)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Index procedurePopulation: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Residual lesion stenosis \<=30% based on visual assessment immediately postprocedure
Outcome measures
| Measure |
Epic Stent
n=166 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Technical Success
|
100 percentage of lesions
|
SECONDARY outcome
Timeframe: In hospital (1-2 days post procedure)Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Technical success (residual lesion stenosis \<=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).
Outcome measures
| Measure |
Epic Stent
n=125 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Procedure Success
|
99.2 percentage of participants
|
SECONDARY outcome
Timeframe: Hospital DischargePopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
Outcome measures
| Measure |
Epic Stent
n=113 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Early Clinical Success
|
44.2 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
Outcome measures
| Measure |
Epic Stent
n=113 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Early Clinical Success
|
87.6 percentage of participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
Outcome measures
| Measure |
Epic Stent
n=109 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Late Clinical Success
|
89.9 percentage of patients
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
Outcome measures
| Measure |
Epic Stent
n=106 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Late Clinical Success
|
95.3 percentage of patients
|
SECONDARY outcome
Timeframe: Hospital DischargePopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.
Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by \>0.15 from the maximum post-procedure value. Reported per limb.
Outcome measures
| Measure |
Epic Stent
n=152 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Early Hemodynamic Success
|
61.2 percentage of limbs
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.
Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by \>0.15 from the maximum post-procedure value. Reported per limb.
Outcome measures
| Measure |
Epic Stent
n=151 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Early Hemodynamic Success
|
66.2 percentage of limbs
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.
Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by \>0.15 from the maximum post-procedure value. Reported per limb.
Outcome measures
| Measure |
Epic Stent
n=141 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Late Hemodynamic Success
|
66.7 percentage of limbs
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.
Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by \>0.15 from the maximum post-procedure value. Reported per limb.
Outcome measures
| Measure |
Epic Stent
n=132 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Late Hemodynamic Success
|
63.6 percentage of limbs
|
SECONDARY outcome
Timeframe: Pre-procedure/baselinePopulation: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic 1. = Mild claudication 2. = Moderate claudication 3. = Severe claudication 4. = Ischemic rest pain 5. = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
Outcome measures
| Measure |
Epic Stent
n=125 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Rutherford Classification Distribution
Major Tissue Loss
|
0.0 percentage of participants
|
|
Rutherford Classification Distribution
Asymptomatic
|
0.0 percentage of participants
|
|
Rutherford Classification Distribution
Mild Claudication
|
7.2 percentage of participants
|
|
Rutherford Classification Distribution
Moderate Claudication
|
33.6 percentage of participants
|
|
Rutherford Classification Distribution
Severe Claudication
|
54.4 percentage of participants
|
|
Rutherford Classification Distribution
Ischemic Rest Pain
|
4.8 percentage of participants
|
|
Rutherford Classification Distribution
Minor Tissue Loss
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Post-procedurePopulation: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.
Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic 1. = Mild claudication 2. = Moderate claudication 3. = Severe claudication 4. = Ischemic rest pain 5. = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
Outcome measures
| Measure |
Epic Stent
n=113 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Rutherford Classification Distribution
Asymptomatic
|
17.7 percentage of participants
|
|
Rutherford Classification Distribution
Mild Claudication
|
20.4 percentage of participants
|
|
Rutherford Classification Distribution
Moderate Claudication
|
35.4 percentage of participants
|
|
Rutherford Classification Distribution
Severe Claudication
|
23.0 percentage of participants
|
|
Rutherford Classification Distribution
Ischemic Rest Pain
|
3.5 percentage of participants
|
|
Rutherford Classification Distribution
Minor Tissue Loss
|
0 percentage of participants
|
|
Rutherford Classification Distribution
Major Tissue Loss
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.
Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic 1. = Mild claudication 2. = Moderate claudication 3. = Severe claudication 4. = Ischemic rest pain 5. = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
Outcome measures
| Measure |
Epic Stent
n=113 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Rutherford Classification Distribution
Minor Tissue Loss
|
0 percentage of participants
|
|
Rutherford Classification Distribution
Asymptomatic
|
65.6 percentage of participants
|
|
Rutherford Classification Distribution
Mild Claudication
|
16.8 percentage of participants
|
|
Rutherford Classification Distribution
Moderate Claudication
|
13.3 percentage of participants
|
|
Rutherford Classification Distribution
Severe Claudication
|
4.4 percentage of participants
|
|
Rutherford Classification Distribution
Ischemic Rest Pain
|
0 percentage of participants
|
|
Rutherford Classification Distribution
Major Tissue Loss
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.
Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss
Outcome measures
| Measure |
Epic Stent
n=109 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Rutherford Classification Distribution
Asymptomatic
|
63.3 percentage of participants
|
|
Rutherford Classification Distribution
Mild Claudication
|
18.3 percentage of participants
|
|
Rutherford Classification Distribution
Moderate Claudication
|
15.6 percentage of participants
|
|
Rutherford Classification Distribution
Severe Claudication
|
2.8 percentage of participants
|
|
Rutherford Classification Distribution
Ischemic Rest Pain
|
0.0 percentage of participants
|
|
Rutherford Classification Distribution
Minor Tissue Loss
|
0.0 percentage of participants
|
|
Rutherford Classification Distribution
Major Tissue Loss
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.
Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss
Outcome measures
| Measure |
Epic Stent
n=106 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Rutherford Classification Distribution
Asymptomatic
|
76.4 percentage of participants
|
|
Rutherford Classification Distribution
Mild Claudication
|
12.3 percentage of participants
|
|
Rutherford Classification Distribution
Moderate Claudication
|
10.4 percentage of participants
|
|
Rutherford Classification Distribution
Severe Claudication
|
0.9 percentage of participants
|
|
Rutherford Classification Distribution
Ischemic Rest Pain
|
0 percentage of participants
|
|
Rutherford Classification Distribution
Minor Tissue Loss
|
0 percentage of participants
|
|
Rutherford Classification Distribution
Major Tissue Loss
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 HoursPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Acute stent thrombosis is defined as occurring \<=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring \>24 hours to \<=30 days following the trial procedure.
Outcome measures
| Measure |
Epic Stent
n=121 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Acute Stent Thrombosis
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: >24 Hours to <=30 Days Post-index procedurePopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring \>24 hours to less than or equal to 30 days following the trial procedure.
Outcome measures
| Measure |
Epic Stent
n=121 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Sub-acute Stent Thrombosis
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Late stent thrombosis is defined as \>30 days to 365 days following the trial procedure.
Outcome measures
| Measure |
Epic Stent
n=118 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Stent Thrombosis
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Late stent thrombosis is defined as \>30 days to 365 days following the trial procedure.
Outcome measures
| Measure |
Epic Stent
n=112 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Stent Thrombosis
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Very late stent thrombosis is defined as \>365 days following the trial procedure.
Outcome measures
| Measure |
Epic Stent
n=106 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Stent Thrombosis
|
2.8 percentage of participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Very late stent thrombosis is defined as \>365 days following the trial procedure.
Outcome measures
| Measure |
Epic Stent
n=101 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Stent Thrombosis
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=161 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
1.9 percentage of lesions
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=157 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
3.2 percentage of lesions
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=150 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
3.3 percentage of lesions
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=143 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
5.6 percentage of lesions
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.
Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
Epic Stent
n=139 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
10.1 percentage of lesions
|
SECONDARY outcome
Timeframe: Pre-procedure/baselinePopulation: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Outcome measures
| Measure |
Epic Stent
n=159 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Ankle-Brachial Index (ABI)
|
0.79 ratio
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Hospital Discharge (1-2 days post-procedure)Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Outcome measures
| Measure |
Epic Stent
n=155 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Ankle-Brachial Index
|
0.96 ratio
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Outcome measures
| Measure |
Epic Stent
n=153 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Ankle-Brachial Index (ABI)
|
0.99 ratio
Standard Deviation .015
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Outcome measures
| Measure |
Epic Stent
n=142 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Ankle-Brachial Index (ABI)
|
0.97 ratio
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Outcome measures
| Measure |
Epic Stent
n=135 Limbs
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Ankle-Brachial Index (ABI)
|
0.96 ratio
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.
Outcome measures
| Measure |
Epic Stent
n=122 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Primary Patency
|
95.9 percentage of lesions
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.
Outcome measures
| Measure |
Epic Stent
n=99 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Primary Patency
|
93.9 percentage of lesions
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.
Outcome measures
| Measure |
Epic Stent
n=122 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Primary-assisted Patency (PAP)
|
98.4 percentage of lesions
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.
Outcome measures
| Measure |
Epic Stent
n=99 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Primary-assisted Patency (PAP)
|
96.0 percentage of lesions
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.
Outcome measures
| Measure |
Epic Stent
n=120 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Secondary Patency
|
100 percentage of lesions
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.
Outcome measures
| Measure |
Epic Stent
n=98 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Secondary Patency
|
98.0 percentage of lesions
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR \>2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.
Outcome measures
| Measure |
Epic Stent
n=122 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Restenosis Assessed by Duplex Ultrasound
|
2.5 percentage of lesions
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.
Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR \>2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.
Outcome measures
| Measure |
Epic Stent
n=99 Lesions
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Restenosis Assessed by Duplex Ultrasound
|
6.1 percentage of lesions
|
SECONDARY outcome
Timeframe: Pre-procedure/baselinePopulation: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=124 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Distance
|
14.56 units on a scale
Standard Deviation 19.36
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=110 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Distance
|
56.35 units on a scale
Standard Deviation 38.97
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=109 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Distance
|
55.88 units on a scale
Standard Deviation 38.02
|
SECONDARY outcome
Timeframe: Pre-procedure/baselinePopulation: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=124 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Speed
|
18.38 units on a scale
Standard Deviation 19.18
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=110 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Speed
|
48.45 units on a scale
Standard Deviation 31.50
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=109 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Speed
|
47.96 units on a scale
Standard Deviation 31.80
|
SECONDARY outcome
Timeframe: Pre-procedure/baselinePopulation: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=124 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score-Stair Climbing
|
26.14 units on a scale
Standard Deviation 26.91
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=110 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Stair Climbing
|
59.39 units on a scale
Standard Deviation 38.08
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.
The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Epic Stent
n=108 Participants
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
|
|---|---|
|
Walking Impairment Questionnaire Score - Stair Climbing
|
57.72 units on a scale
Standard Deviation 37.17
|
Adverse Events
ORION
Serious adverse events
| Measure |
ORION
n=125 participants at risk
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
1/125 • Number of events 3 • 3 Years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Cardiac disorders
Angina Pectoris
|
5.6%
7/125 • Number of events 8 • 3 Years
|
|
Cardiac disorders
Angina Unstable
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
7/125 • Number of events 10 • 3 Years
|
|
Cardiac disorders
Cardiac Arrest
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Cardiac disorders
Coronary Artery Disease
|
3.2%
4/125 • Number of events 5 • 3 Years
|
|
Cardiac disorders
Coronary Artery Stenosis
|
2.4%
3/125 • Number of events 3 • 3 Years
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Cardiac disorders
Myocardial Infarction
|
2.4%
3/125 • Number of events 3 • 3 Years
|
|
Eye disorders
Blindness
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
2/125 • Number of events 3 • 3 Years
|
|
Gastrointestinal disorders
Constipation
|
0.80%
1/125 • Number of events 2 • 3 Years
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Gastrointestinal disorders
Ileus
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
General disorders
Catheter Site Haematoma
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
General disorders
Catheter Site Haemorrhage
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
General disorders
Chest discomfort
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
General disorders
Non-cardiac Chest Pain
|
3.2%
4/125 • Number of events 5 • 3 Years
|
|
General disorders
Oedema Peripheral
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Infections and infestations
Abdominal Abscess
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Infections and infestations
Clostridial Infection
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Infections and infestations
Diverticulitis
|
0.80%
1/125 • Number of events 2 • 3 Years
|
|
Infections and infestations
Pneumonia
|
4.8%
6/125 • Number of events 7 • 3 Years
|
|
Infections and infestations
Wound Infection
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Stent-graft Malfunction
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Investigations
Blood Creatinine Increased
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent Cancer
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Nervous system disorders
Carotid Artery Stenosis
|
3.2%
4/125 • Number of events 5 • 3 Years
|
|
Nervous system disorders
Diplegia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Nervous system disorders
Headache
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Nervous system disorders
Hypoaesthesia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Psychiatric disorders
Mental Status Changes
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
4.0%
5/125 • Number of events 8 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Vascular disorders
Angiodysplasia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Arterial Stenosis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Iliac Artery Thrombosis
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Vascular disorders
Intermittent Claudication
|
4.0%
5/125 • Number of events 7 • 3 Years
|
|
Vascular disorders
Peripheral Artery Dissection
|
2.4%
3/125 • Number of events 3 • 3 Years
|
|
Vascular disorders
Peripheral Ischaemia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Thrombosis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Vascular Occlusion
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Vessel Perforation
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Cardiac disorders
Bradycardia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.4%
3/125 • Number of events 3 • 3 Years
|
|
Cardiac disorders
Sinus Arrhythmia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Eye disorders
Cataract
|
1.6%
2/125 • Number of events 3 • 3 Years
|
|
Gastrointestinal disorders
Ascites
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.80%
1/125 • Number of events 2 • 3 Years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
General disorders
Chest Pain
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Infections and infestations
Bronchiectasis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Infections and infestations
Bronchitis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Infections and infestations
Cellulitis
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Infections and infestations
Septic Shock
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Infections and infestations
Urinary Tract Infection
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Chemical Eye Injury
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Fall
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage IV
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Peritoneal Neoplasm
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.4%
3/125 • Number of events 3 • 3 Years
|
|
Nervous system disorders
Convulsion
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Psychiatric disorders
Depression
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.80%
1/125 • Number of events 2 • 3 Years
|
|
Renal and urinary disorders
Haematuria
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Renal and urinary disorders
Renal Mass
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
3/125 • Number of events 3 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Aortic Aneurysm
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.80%
1/125 • Number of events 3 • 3 Years
|
|
Vascular disorders
Hypertension
|
1.6%
2/125 • Number of events 2 • 3 Years
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Iliac Artery Stenosis
|
4.8%
6/125 • Number of events 6 • 3 Years
|
|
Vascular disorders
Leriche Syndrome
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.80%
1/125 • Number of events 1 • 3 Years
|
|
Vascular disorders
Subclavian Steal Syndrome
|
0.80%
1/125 • Number of events 1 • 3 Years
|
Other adverse events
| Measure |
ORION
n=125 participants at risk
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
|
|---|---|
|
General disorders
Catheter Site Haematoma
|
8.0%
10/125 • Number of events 10 • 3 Years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.2%
14/125 • Number of events 17 • 3 Years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.0%
15/125 • Number of events 22 • 3 Years
|
|
Cardiac disorders
Angina Pectoris
|
5.6%
7/125 • Number of events 7 • 3 Years
|
|
Infections and infestations
Bronchitis
|
5.6%
7/125 • Number of events 8 • 3 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
10/125 • Number of events 11 • 3 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER