N/A
N=57
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
Atherosclerosis of Native Arteries of the Extremities
Bottom Line
View on ClinicalTrials.gov: NCT01820637 ↗Enrolled (actual)
57
Serious AEs
59.7%
Results posted
Mar 2019
Primary outcome: Primary: Primary Patency — 94.4 percentage of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency |
94.4 | — |
Summary
To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
Eligibility Criteria
Inclusion Criteria
- Subjects age 18 and older
- Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
- Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:
- Degree of stenosis ≥70% by visual angiographic assessment
- Vessel diameter ≥ 4 and ≤ 6mm
- Total lesion length (or series of lesions) ≥30 mm and ≤110 mm
- (Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)
- Target lesion located at least three centimeters above the inferior edge of the femur
- Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot
Data sourced from ClinicalTrials.gov (NCT01820637). 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.