Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

Last updated: April 11, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Vascular Diseases

Peripheral Arterial Occlusive Disease

Treatment

Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.

Clinical Study ID

NCT04674969
S2444
  • Ages > 18
  • All Genders

Study Summary

The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years and older

  • Written informed consent (patient data release-form)

  • Use of any commercially available Boston Scientific drug-eluting device marketed fortreatment of lesions in the peripheral vasculature and specified in the RegistryEnrollment Guide

Exclusion

Exclusion Criteria:

  • Life expectancy of <1 year

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
Phase:
Study Start date:
March 29, 2021
Estimated Completion Date:
January 31, 2028

Study Description

A global prospective, non-randomized, open-label, multi-center Registry to collect Real-World Data, including health economic data, to support the use of commercially available drug-eluting BSC devices for the treatment of lesions located in the peripheral vasculature.

Connect with a study center

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Royal North Shore Hospital

    St. Leonards, 2065
    Australia

    Active - Recruiting

  • Medizinische Univ.-Kliniken Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Peter Lougheed Centre-Hospital

    Calgary, Alberta
    Canada

    Active - Recruiting

  • CHUS

    Sherbrooke, Quebec J1H5N4
    Canada

    Site Not Available

  • CHUS - Hotel Dieu

    Sherbrooke, Quebec J1H5N4
    Canada

    Active - Recruiting

  • Beijing Anzhen Hospital of the Capital University of Medical Sciences

    Chaoyang, Beijing
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Chaoyang, Beijing
    China

    Site Not Available

  • Xuanwu Hospital Capital Medical University

    Xicheng, Beijing
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • Zhongshan University No.1 Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Affiliated Hospital of Medical College Qingdao University

    Qingdao, Shandong
    China

    Site Not Available

  • Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine

    Huangpu, Shanghai
    China

    Site Not Available

  • Shanghai Changhai Hospital

    Yangpu, Shanghai
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi
    China

    Site Not Available

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Site Not Available

  • Shanghai Zhongshan Hospital

    Shanghai, Xuhui District
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Hospital Marie Lannelongue

    Le Plessis-Robinson, 92350
    France

    Active - Recruiting

  • Hospital Paris Saint Joseph

    Paris,
    France

    Active - Recruiting

  • Fürst Stirum Klinik Bruchsal Hospital

    Bruchsal,
    Germany

    Active - Recruiting

  • University Clinic Essen-Hospital

    Essen,
    Germany

    Active - Recruiting

  • Klinikum der Ludwig-Maximilians-Universitat

    München,
    Germany

    Active - Recruiting

  • Uniwersyteckim Szpitalem Klinicznym w Poznaniu

    Poznań, 60-355
    Poland

    Active - Recruiting

  • Corporacio Sanitaria Parc Taulí, Barcelona

    Sabadell,
    Spain

    Active - Recruiting

  • Hospital Parc Tauli

    Sabadell,
    Spain

    Site Not Available

  • China Medical University Hospital

    Taichung, 40408
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei City,
    Taiwan

    Active - Recruiting

  • Siriraj Hospital Department of Surgery

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Prince of Songkla University

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • Huntsville Hospital

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Modern Vascular

    Mesa, Arizona 85203
    United States

    Site Not Available

  • St. Bernard's Medical Center

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Cedars - Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Cedars Sinai

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • PIH Health Good Samaritan Hospital

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Sutter Medical Center, Sacramento

    Sacramento, California 95816
    United States

    Site Not Available

  • Adventist Health St Helena Hospital

    Saint Helena, California 94574
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Christiana Hospital

    Newport, Delaware 19718
    United States

    Active - Recruiting

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Palm Beach Heart & Vascular, LLC

    Boynton Beach, Florida 33436
    United States

    Site Not Available

  • Holmes Regional Medical Center

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Tallahassee Memorial Hospital

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • South Georgia Medical Center

    Valdosta, Georgia 31602
    United States

    Active - Recruiting

  • Rush University

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • St. John's Hospital/ Prairie Education and Research Cooperative

    Springfield, Illinois 62701
    United States

    Site Not Available

  • St. Joseph Hospital/Dupont Hospital

    Fort Wayne, Indiana 46774
    United States

    Site Not Available

  • Ascension St. Vincent's Hospital

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • CIS Clinical Research Corporation

    Houma, Louisiana 70360
    United States

    Site Not Available

  • Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    Kenner, Louisiana 70121
    United States

    Active - Recruiting

  • Ochsner Health

    Kenner, Louisiana 70121
    United States

    Site Not Available

  • Cardiovascular Institute of the South

    Lafayette, Louisiana 70506
    United States

    Site Not Available

  • Saint Agnes Hospital

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Mercy Hospital (Allina Health)

    Coon Rapids, Minnesota 55432
    United States

    Site Not Available

  • United Heart and Vascular

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo, Mississippi 38804
    United States

    Active - Recruiting

  • Deborah Heart & Lung Center

    Brown Mills, New Jersey 08015
    United States

    Site Not Available

  • Deborah Heart & Lung Center

    Browns Mills, New Jersey 08015
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Active - Recruiting

  • Robert Wood Johnson/Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Site Not Available

  • Buffalo General Hospital

    Buffalo, New York 55313
    United States

    Active - Recruiting

  • North Shore University Hospital/Northwell Health

    Manhasset, New York 11030
    United States

    Site Not Available

  • Columbia University

    New York, New York 10027
    United States

    Site Not Available

  • Memorial Sloan Kettering Hospital

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • New York University Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medicine/New York-Presbyterian Hospita

    New York, New York 10065
    United States

    Active - Recruiting

  • Weill Cornell Medicine/New York-Presbyterian Hospital

    New York, New York 10065
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Rex UNC Health (NC Heart and Vascular Research, LLC)

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Premier Cardiovascular Institute

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Ascension St. John Clinical Research Institute

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Pinnacle Health Cardiovascular Institute

    Harrisburg, Pennsylvania 17043
    United States

    Site Not Available

  • Hospital University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Monument Health Rapid City Hospital, Inc.

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Ascension Seton Medical Center Austin

    Austin, Texas 78705
    United States

    Site Not Available

  • Seton Medical Center

    Austin, Texas 78705
    United States

    Active - Recruiting

  • The University of Texas, Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    Lubbock, Texas 79430
    United States

    Completed

  • HeartPlace

    Plano, Texas 75075
    United States

    Site Not Available

  • HeartPlace P.A.

    Plano, Texas 75075
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Fairfax, Virginia 22042
    United States

    Active - Recruiting

  • UW Medicine - Harborview Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

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