This trial is active, not recruiting.

Conditions peripheral vascular diseases, claudication
Treatment protÉgÉ® everflex™ self-expanding stent system
Phase phase 2/phase 3
Sponsor Covidien
Start date August 2007
End date March 2012
Trial size 287 participants
Trial identifier NCT00530712, P-2424


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Primary patency
time frame: 1 Year
Major Adverse Events
time frame: 30 Days

Secondary Outcomes

Single-Stent Primary Patency
time frame: 1 Year
Single-Stent Major Adverse Events
time frame: 30 Days
Major Adverse Events
time frame: 1 Year
Stent Fracture Rate
time frame: 1, 2 and 3 Years
Decline in Rutherford Clinical Category
time frame: 30 Days
Improvement in Rutherford Clinical Category
time frame: 1 Year
Increase in ABI
time frame: 1 Year
Assisted Primary Patency
time frame: 1 Year
Secondary Patency
time frame: 1 Year
Absolute Claudication Distance Improvement
time frame: 1 Year
Walking Improvement
time frame: 1 Year
Duplex Ultrasound ≤ 2.4 Primary Patency
time frame: 1 Year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Jon Matsumura, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Covidien.