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

Not Applicable

Completed

• Conditions: Atherosclerosis of Native Arteries of the Extremities
• Interventions: Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test device arm (DES SFA)	The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)	Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

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)

Prince of Wales Hospital; 🇦🇺 Randwick, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, Australia

Allgemeines Krankenhaus AKH; 🇦🇹 Vienna, Austria, Austria

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

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

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

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Universität Leipzig; 🇩🇪 Leipzig, Germany

Braemar Hospital; 🇳🇿 Hamilton, New Zealand

Middlemore Hospital; 🇳🇿 Otahuhu, New Zealand

AZ Sint-Blasius; 🇧🇪 Dendermonde, Belgium

Regionaal Ziekenhuis Heilig Hart Tienen; 🇧🇪 Tienen, Belgium