N/A
N=287
Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis
Peripheral Vascular Diseases · Claudication
Bottom Line
View on ClinicalTrials.gov: NCT00530712 ↗Enrolled (actual)
287
Serious AEs
34.5%
Results posted
Aug 2014
Primary outcome: Primary: Primary Patency — 67.7 Percentage of participants with data
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PROTÉGÉ® EverFlex™ Self-Expanding Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency |
67.7 | — |
| PRIMARY Major Adverse Events |
16.8; 2.9; 0; 13.9 | — |
| SECONDARY Single-Stent Primary Patency |
68.7 | — |
| SECONDARY Single-Stent Major Adverse Events |
— | — |
| SECONDARY Major Adverse Events |
16.8; 2.9; 0; 13.9 | — |
| SECONDARY Stent Fracture Rate |
0.4; 1; 0 | — |
| SECONDARY Number of Participants With Decline in Rutherford Clinical Category |
— | — |
| SECONDARY Improvement in Rutherford Clinical Category |
83.6 | — |
| SECONDARY Increase in Ankle-Brachial Index From Baseline to 1 Year |
0.65; 0.89 | — |
| SECONDARY Assisted Primary Patency |
86.9 | — |
| SECONDARY Secondary Patency |
87.3 | — |
| SECONDARY Absolute Claudication Distance Improvement |
0.23; 0.28 | — |
| SECONDARY Walking Improvement |
36.8 | — |
| SECONDARY Duplex Ultrasound ≤ 2.4 Primary Patency |
77.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00530712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.