Status:
COMPLETED
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atherosclerosis of Native Arteries of the Extremities
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
- 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
Exclusion
Key Trial Info
Start Date :
August 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01820637
Start Date
August 23 2013
End Date
February 20 2017
Last Update
March 22 2019
Active Locations (13)
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1
Royal Prince Alfred Hospital
Camperdown, Australia
2
Prince of Wales Hospital
Randwick, Australia
3
Allgemeines Krankenhaus AKH
Vienna, Austria, Austria
4
AZ Sint-Blasius
Dendermonde, Belgium, 9200