Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project

Not Applicable

Completed

• Conditions: Atherosclerosis of Native Arteries of the Extremities

• Registration Number: NCT01820637
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Study Start: 2013-08-23
• Primary Completion: 2014-12
• Study Completion: 2017-02-20
• Results First Submitted: 2018-05-08
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Results First Posted: 2019-03-22
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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:

  1. Degree of stenosis ≥70% by visual angiographic assessment

  2. Vessel diameter ≥ 4 and ≤ 6mm

  3. 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)

  4. 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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Patency	9-months	Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.

Trial Locations

Locations (13)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, Australia

Allgemeines Krankenhaus AKH; 🇦🇹 Vienna, Austria, Austria

AZ Sint-Blasius; 🇧🇪 Dendermonde, Belgium

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Regionaal Ziekenhuis Heilig Hart Tienen; 🇧🇪 Tienen, Belgium

Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH; 🇩🇪 Bad Krozingen, Germany

Ev. Luth. Diakonissenanstalt Flensburg; 🇩🇪 Flensburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universität Leipzig; 🇩🇪 Leipzig, Germany

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