Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II)
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ClinicalTrials.gov Identifier: NCT00530712 |
Recruitment Status :
Completed
First Posted : September 17, 2007
Results First Posted : August 15, 2014
Last Update Posted : February 18, 2019
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Vascular Diseases Claudication | Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 287 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | July 2013 |
Arm | Intervention/treatment |
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Experimental: PTA and Stenting with EverFlex device
Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System
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Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System
Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery. |
- Primary Patency [ Time Frame: 1 Year ]Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.
- Major Adverse Events [ Time Frame: 30 Days ]Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)
- Single-Stent Primary Patency [ Time Frame: 1 Year ]Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.
- Single-Stent Major Adverse Events [ Time Frame: 30 Days ]MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.
- Major Adverse Events [ Time Frame: 1 Year ]MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.
- Stent Fracture Rate [ Time Frame: 1, 2 and 3 Years ]Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.
- Number of Participants With Decline in Rutherford Clinical Category [ Time Frame: 30 days ]Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.
- Improvement in Rutherford Clinical Category [ Time Frame: 1 year ]Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.
- Increase in Ankle-Brachial Index From Baseline to 1 Year [ Time Frame: 1 Year ]Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.
- Assisted Primary Patency [ Time Frame: 1 Year ]Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.
- Secondary Patency [ Time Frame: 1 Year ]Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
- Absolute Claudication Distance Improvement [ Time Frame: 1 Year ]Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.
- Walking Improvement [ Time Frame: 1 Year ]Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.
- Duplex Ultrasound ≤ 2.4 Primary Patency [ Time Frame: 1 Year ]Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
- Symptomatic femoral-popliteal atherosclerosis.
- Willing to comply with all follow-up evaluations at the specified times.
- Provides written informed consent prior to enrollment in the study.
Exclusion Criteria:
- Previously implanted stent(s) or stent graft(s) in the target vessel.
- Planned use of devices other than angioplasty balloons during procedure.
- Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
- Life expectancy of less than 12 months.
- Symptomatic femoral disease in the opposite limb.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530712
Principal Investigator: | Jon Matsumura, MD | University of Wisconsin, Madison | |
Principal Investigator: | Krishna Rocha-Singh, MD | Prairie Heart Institute |
Responsible Party: | Medtronic Endovascular |
ClinicalTrials.gov Identifier: | NCT00530712 |
Other Study ID Numbers: |
P-2424 |
First Posted: | September 17, 2007 Key Record Dates |
Results First Posted: | August 15, 2014 |
Last Update Posted: | February 18, 2019 |
Last Verified: | February 2019 |
SFA Popliteal Stent EverFlex |
Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Atherosclerosis |