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NCT04674969Recruiting

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

Boston Scientific Corporation

Start Date

3/29/2021

Completion Date

1/1/2028

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 for treatment of lesions in the peripheral vasculature and specified in the Registry Enrollment Guide Exclusion Criteria: * Life expectancy of \<1 year

Interventions

DEVICE

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

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Conditions

Peripheral Vascular Diseases

Locations

St. Bernard's Medical Center

Jonesboro, Arkansas 72401

United States

PIH Health Good Samaritan Hospital

Los Angeles, California 90017

United States

Cedars - Sinai Medical Center

Los Angeles, California 90048

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

United States

Sutter Medical Center, Sacramento

Sacramento, California 95816

United States

Adventist Health St Helena Hospital

St. Helena, California 94574

United States

Yale University School of Medicine

New Haven, Connecticut 06510

United States

Christiana Hospital

Newport, Delaware 19718

United States

Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Palm Beach Heart & Vascular, LLC

Boynton Beach, Florida 33436

United States

Tallahassee Memorial Hospital

Tallahassee, Florida 32308

United States

Emory University Hospital

Atlanta, Georgia 30303

United States

South Georgia Medical Center

Valdosta, Georgia 31602

United States

Rush University

Chicago, Illinois 60612

United States

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

Springfield, Illinois 62701

United States

St. Joseph Hospital/Dupont Hospital

Fort Wayne, Indiana 46774

United States

Ascension St. Vincent's Hospital

Indianapolis, Indiana 46260

United States

CIS Clinical Research Corporation

Houma, Louisiana 70360

United States

Ochsner Clinic Foundation

Kenner, Louisiana 70121

United States

Cardiovascular Institute of the South

Lafayette, Louisiana 70506

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Mercy Hospital (Allina Health)

Coon Rapids, Minnesota 55432

United States

North Mississippi Medical Center

Tupelo, Mississippi 38804

United States

Deborah Heart & Lung Center

Browns Mills, New Jersey 08015

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Newark Beth Israel Medical Center

Newark, New Jersey 07112

United States

Buffalo General Hospital

Buffalo, New York 55313

United States

North Shore University Hospital/Northwell Health

Manhasset, New York 11030

United States

New York University Medical Center

New York, New York 10016

United States

Columbia University

New York, New York 10027

United States

Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Hospital

New York, New York 10065

United States

Weill Cornell Medicine/New York-Presbyterian Hospital

New York, New York 10065

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

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

Raleigh, North Carolina 27607

United States

University Hospitals of Cleveland

Cleveland, Ohio 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Premier Cardiovascular Institute

Dayton, Ohio 45409

United States

Ascension St. John Clinical Research Institute

Tulsa, Oklahoma 74104

United States

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania 17043

United States

Hospital University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

The Miriam Hospital

Providence, Rhode Island 02906

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Monument Health Rapid City Hospital, Inc.

Rapid City, South Dakota 57701

United States

Seton Medical Center

Austin, Texas 78705

United States

The University of Texas, Southwestern Medical Center

Dallas, Texas 75390

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Texas Tech University Health Sciences Center

Lubbock, Texas 79430

United States

HeartPlace P.A.

Plano, Texas 75075

United States

Inova Fairfax Hospital

Fairfax, Virginia 22042

United States

UW Medicine - Harborview Medical Center

Seattle, Washington 98104

United States

Royal Perth Hospital

Perth, Western Australia 6000

Australia

Royal North Shore Hospital

St Leonards, 2065

Australia

Medizinische Univ.-Kliniken Graz

Graz, 8036

Austria

Peter Lougheed Centre-Hospital

Calgary, Alberta

Canada

CHUS - Hotel Dieu

Sherbrooke, Quebec J1H5N4

Canada

Beijing Anzhen Hospital of the Capital University of Medical Sciences

Chaoyang, Beijing Municipality

China

China-Japan Friendship Hospital

Chaoyang, Beijing Municipality

China

Xuanwu Hospital Capital Medical University

Xicheng, Beijing Municipality

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality

China

Zhongshan University No.1 Hospital

Guangzhou, Guangdong

China

Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong

China

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

Huangpu, Shanghai Municipality

China

Shanghai Changhai Hospital

Yangpu, Shanghai Municipality

China

Shanxi Bethune Hospital

Taiyuan, Shanxi

China

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

Xi’an, Shanxi

China

Shanghai Zhongshan Hospital

Shanghai, Xuhui District

China

Hospital Marie Lannelongue

Le Plessis-Robinson, 92350

France

Hospital Paris Saint Joseph

Paris,

France

Fürst Stirum Klinik Bruchsal Hospital

Bruchsal,

Germany

University Clinic Essen-Hospital

Essen,

Germany

Klinikum der Ludwig-Maximilians-Universitat

München,

Germany

Uniwersyteckim Szpitalem Klinicznym w Poznaniu

Poznan, 60-355

Poland

Corporacio Sanitaria Parc Taulí, Barcelona

Sabadell,

Spain

China Medical University Hospital

Taichung, 40408

Taiwan

National Taiwan University Hospital

Taipei,

Taiwan

Siriraj Hospital Department of Surgery

Bangkok, 10700

Thailand

Prince of Songkla University

Hat Yai, 90110

Thailand