Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II)
This study has been completed.
Sponsor:
Covidien
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00530712
First received: September 14, 2007
Last updated: July 28, 2014
Last verified: July 2014
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Purpose
This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Vascular Diseases Claudication |
Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Vascular Diseases
Drug Information available for:
Menthol
U.S. FDA Resources
Further study details as provided by Covidien:
Primary Outcome Measures:
- Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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)
Secondary Outcome Measures:
- Single-Stent Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. only 1 year data presented here.
- Decline in Rutherford Clinical Category [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Defined as an increase of one or more categories in RCC compared to baseline.
- Improvement in Rutherford Clinical Category [ Time Frame: 1 Year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Duplex Ultrasound ≤ 2.4 Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]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.
| Enrollment: | 287 |
| Study Start Date: | August 2007 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530712
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530712
Sponsors and Collaborators
Covidien
Investigators
| Principal Investigator: | Jon Matsumura, MD | University of Wisconsin, Madison | |
| Principal Investigator: | Krishna Rocha-Singh, MD | Prairie Heart Institute |
More Information
Publications:
| Responsible Party: | Covidien |
| ClinicalTrials.gov Identifier: | NCT00530712 History of Changes |
| Other Study ID Numbers: | P-2424 |
| Study First Received: | September 14, 2007 |
| Results First Received: | July 28, 2014 |
| Last Updated: | July 28, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Covidien:
|
SFA Popliteal Stent EverFlex |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis |
Atherosclerosis Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015