A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

Status: Completed
Location: See all (68) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Subjects age 18 and older.

• Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits. NOTE: For subjects less than 20 years of age enrolled at a Japanese center, the subject's legal representative, as well as the subject, must provide written informed consent.

• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.

• Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA:

• Degree of stenosis ≥ 70% by visual angiographic assessment

• Vessel diameter ≥ 4 and ≤ 6 mm

• Total lesion length (or series of lesions) ≥ 30 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or up to two Zilver PTX stents)

• Long Lesion Substudy: Total lesion length (or series of lesions) >140 mm and ≤ 190 mm (Note: Lesion segment(s) will require overlapping of two ELUVIA stents).

• For occlusive lesions requiring use of re-entry device, lesion length ≤ 120 mm

• Long Lesion Substudy: For occlusive lesions requiring use of re-entry device, lesion length > 120 mm and ≤ 170 mm

• 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 with no planned intervention.

Locations
United States
Arizona
Yuma Regional Medical Center
Yuma
California
University of California, Davis Medical Center
Sacramento
Florida
Florida Research Network, LLC
Gainesville
First Coast Cardiovascular Institute
Jacksonville
Baptist Cardiac and Vascular Institute
Miami
Mount Sinai Medical Center
Miami Beach
MediQuest Research at Munroe Regional Medical Center
Ocala
Baptist Hospital
Pensacola
Georgia
University Hospital
Augusta
Illinois
Advocate Christ Medical Center
Oak Lawn
St. Francis Medical Center
Peoria
Indiana
St. Joseph Hospital
Fort Wayne
Massachusetts
Steward St. Elizabeth's Medical Center of Boston, Inc.
Boston
Maine
Maine Medical Center
Portland
Michigan
Northern Michigan Hospital
Petoskey
Minnesota
Mercy Hospital
Coon Rapids
Mayo Clinic Foundation
Rochester
North Carolina
Carolinas HealthCare System NorthEast
Concord
Rex Hospital
Raleigh
Nebraska
Alegent Creighton Health Bergan Mercy Medical Center
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Hackensack University Medical Center
Hackensack
New Mexico
New Mexico Heart Institute, PA
Albuquerque
New York
Maimonides Medical Center
Brooklyn
New York Presbyterian Hospital-Columbia University Medical Center
New York
New York University Medical Center
New York
Ohio
Aultman Hospital
Canton
University of Toledo Medical Center
Toledo
LakeWest Hospital/Northeast Ohio Vascular Associates, Inc.
Willoughby
Oregon
Providence St. Vincents Medical Center
Portland
Pennsylvania
Lankenau Institute for Medical Research
Bryn Mawr
Albert Einstein Medical Center
Philadelphia
Pinnacle Health Cardiovascular Institute
Wormleysburg
York Hospital
York
South Dakota
Avera Heart Hospital of South Dakota
Sioux Falls
Tennessee
University Surgical Associates
Chattanooga
Jackson-Madison County General Hospital
Jackson
St. Thomas Research Institute, LLC
Nashville
Texas
Texas Health Presbyterian Hospital
Dallas
The Methodist Hospital Research Institute
Houston
The Heart Hospital Baylor Plano
Plano
Wisconsin
Aspirus Heart and Vascular Institute - Research and Education
Wausau
Other Locations
Austria
Medical University Graz, Department of Radiology
Graz
Allgemeines Krankenhaus AKH
Vienna
Hanusch Hospital
Vienna
Belgium
Ziekenhuis oost Limburg
Genk
Universitair Ziekenhuis Gent
Gent
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen
Canada
Fleurimont Hospital
Sherbrooke
Toronto General Hospital
Toronto
Germany
Universitäts-Herzzentrum Bad Krozingen
Bad Krozingen
Center for Diagnostic Radiology and Minimally Invasive Therapy at The Jewish Hospital Berlin
Berlin
Vivantes Klinikum Neukölln
Berlin
Ev. Luth. Diakonissenanstalt Flensburg
Flensburg
Universität Leipzig
Leipzig
Japan
Kansai Rosai Hospital
Amagasaki
Fukuoka Sanno Hospital
Fukuoka
Nara Medical University Hospital
Kashihara-shi
Takatsu General Hospital
Kawasaki
Kishiwada Tokushukai Hospital
Kishiwada
Kokura Memorial Hospital
Kitakyushu
Toho University Ohashi Medical Center
Meguro
The Jikei University Hospital
Minato
Morinomiya Hospital
Osaka
Saiseikai Yokohama-City Eastern Hospital
Yokohama
New Zealand
Auckland City Hospital
Auckland
Middlemore Hospital
Auckland
Clinical Trials NZ
Hamilton
Time Frame
Start Date: December 2015
Completion Date: April 12, 2022
Participants
Target number of participants: 524
Treatments
Experimental: ELUVIA Stent Implantation
Percutaneous stent placement in the SFA/PPA
Active Comparator: Zilver PTX Stent Implantation
Percutaneous stent placement in the SFA/PPA
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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