Peripheral Vascular Disease - DURABILITY II
| printer friendly |
Trial Sponsor
eV3
Principal Investigator
Jeff Goldstein, MD
Trial Name
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
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.
Phase
Phase II/III
Study Type
Interventional
Study Design
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study Arms
1
Expected Enrollment
287
Study Start
August 2007
Expected Completion
August 2011
Primary Outcome Measures
- Primary patency within 1 year of procedure
- Major Adverse Events within 30 days
Secondary Outcome Measures
- Single-Stent Primary Patency within 1 year
- Single-Stent Major Adverse Events within 30 days
- Major Adverse Events within 1 year
- Stent Fracture Rate at 1, 2 and 3 years
- Decline in Rutherford Clinical Category within 30 days
- Improvement in Rutherford Clinical Category within 1 year
- Increase in ABI within 1 year
- Assisted Primary Patency within 1 year
- Secondary Patency within 1 year
- Absolute Claudication Distance Improvement within 1 year
- Walking Improvement within 1 year
- Duplex Ultrasound ≤ 2.4 Primary Patency within 1 year
Eligibility
Ages Eligible for Study
18 years or older
Genders Eligible for Study
Both
Inclusion Criteria
- Stenotic, restenotic (from angioplasty only) 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.
*Adobe Reader required.
 |
