Clinical trial NCT00530712: Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Claudication
Keywords: SFA
Popliteal
Stent
EverFlex
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Primary Patency
timeFrame: 1 Year
measure: Major Adverse Events
timeFrame: 30 Days
Secondary outcomes:
measure: Single-Stent Primary Patency
timeFrame: 1 Year
measure: Single-Stent Major Adverse Events
timeFrame: 30 Days
measure: Major Adverse Events
timeFrame: 1 Year
measure: Stent Fracture Rate
timeFrame: 1, 2 and 3 Years
measure: Number of Participants With Decline in Rutherford Clinical Category
timeFrame: 30 days
measure: Improvement in Rutherford Clinical Category
timeFrame: 1 year
measure: Increase in Ankle-Brachial Index From Baseline to 1 Year
timeFrame: 1 Year
measure: Assisted Primary Patency
timeFrame: 1 Year
measure: Secondary Patency
timeFrame: 1 Year
measure: Absolute Claudication Distance Improvement
timeFrame: 1 Year
measure: Walking Improvement
timeFrame: 1 Year
measure: Duplex Ultrasound ≤ 2.4 Primary Patency
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Jon Matsumura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prairie Heart Institute
name: Krishna Rocha-Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2.