Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)
Status: Recruiting
Location: See all (79) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
St. Bernard's Medical Center
RECRUITING
Jonesboro
California
Cedars - Sinai Medical Center
RECRUITING
Los Angeles
PIH Health Good Samaritan Hospital
RECRUITING
Los Angeles
Ronald Reagan UCLA Medical Center
WITHDRAWN
Los Angeles
Sutter Medical Center, Sacramento
COMPLETED
Sacramento
Adventist Health St Helena Hospital
RECRUITING
St. Helena
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Washington, D.c.
Washington Hospital Center
RECRUITING
Washington D.c.
Delaware
Christiana Hospital
RECRUITING
Newport
Florida
Palm Beach Heart & Vascular, LLC
WITHDRAWN
Boynton Beach
Tallahassee Memorial Hospital
RECRUITING
Tallahassee
Georgia
Emory University Hospital
RECRUITING
Atlanta
South Georgia Medical Center
RECRUITING
Valdosta
Illinois
Rush University
RECRUITING
Chicago
St. John's Hospital/ Prairie Education and Research Cooperative
RECRUITING
Springfield
Indiana
St. Joseph Hospital/Dupont Hospital
WITHDRAWN
Fort Wayne
Ascension St. Vincent's Hospital
RECRUITING
Indianapolis
Louisiana
CIS Clinical Research Corporation
COMPLETED
Houma
Ochsner Clinic Foundation
RECRUITING
Kenner
Cardiovascular Institute of the South
WITHDRAWN
Lafayette
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Minnesota
Mercy Hospital (Allina Health)
ACTIVE_NOT_RECRUITING
Coon Rapids
Mississippi
North Mississippi Medical Center
RECRUITING
Tupelo
North Carolina
Duke University Medical Center
RECRUITING
Durham
Rex UNC Health (NC Heart and Vascular Research, LLC)
RECRUITING
Raleigh
New Jersey
Deborah Heart & Lung Center
ACTIVE_NOT_RECRUITING
Browns Mills
Hackensack University Medical Center
RECRUITING
Hackensack
Newark Beth Israel Medical Center
RECRUITING
Newark
New York
Buffalo General Hospital
RECRUITING
Buffalo
North Shore University Hospital/Northwell Health
ACTIVE_NOT_RECRUITING
Manhasset
Columbia University
RECRUITING
New York
Memorial Sloan Kettering Hospital
RECRUITING
New York
Mount Sinai
RECRUITING
New York
New York University Medical Center
RECRUITING
New York
Weill Cornell Medicine/New York-Presbyterian Hospital
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
University Hospitals of Cleveland
RECRUITING
Cleveland
Premier Cardiovascular Institute
COMPLETED
Dayton
Oklahoma
Ascension St. John Clinical Research Institute
RECRUITING
Tulsa
Pennsylvania
Pinnacle Health Cardiovascular Institute
COMPLETED
Harrisburg
Hospital University of Pennsylvania
RECRUITING
Philadelphia
Thomas Jefferson University
RECRUITING
Philadelphia
Rhode Island
The Miriam Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina
ACTIVE_NOT_RECRUITING
Charleston
South Dakota
Monument Health Rapid City Hospital, Inc.
COMPLETED
Rapid City
Texas
Seton Medical Center
RECRUITING
Austin
The University of Texas, Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
Texas Tech University Health Sciences Center
COMPLETED
Lubbock
HeartPlace P.A.
RECRUITING
Plano
Virginia
Inova Fairfax Hospital
RECRUITING
Fairfax
Washington
UW Medicine - Harborview Medical Center
RECRUITING
Seattle
Other Locations
Australia
Royal Perth Hospital
RECRUITING
Perth
Royal North Shore Hospital
RECRUITING
St Leonards
Austria
Medizinische Univ.-Kliniken Graz
RECRUITING
Graz
Canada
Peter Lougheed Centre-Hospital
RECRUITING
Calgary
CHUS - Hotel Dieu
ACTIVE_NOT_RECRUITING
Sherbrooke
China
Beijing Anzhen Hospital of the Capital University of Medical Sciences
ACTIVE_NOT_RECRUITING
Chaoyang
China-Japan Friendship Hospital
ACTIVE_NOT_RECRUITING
Chaoyang
The First Affiliated Hospital of Chongqing Medical University
ACTIVE_NOT_RECRUITING
Chongqing
Zhongshan University No.1 Hospital
ACTIVE_NOT_RECRUITING
Guangzhou
Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine
ACTIVE_NOT_RECRUITING
Huangpu
Affiliated Hospital of Medical College Qingdao University
ACTIVE_NOT_RECRUITING
Qingdao
Shanghai Zhongshan Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Shanxi Bethune Hospital
ACTIVE_NOT_RECRUITING
Taiyuan
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
ACTIVE_NOT_RECRUITING
Xi’an
Xuanwu Hospital Capital Medical University
ACTIVE_NOT_RECRUITING
Xicheng
Shanghai Changhai Hospital
ACTIVE_NOT_RECRUITING
Yangpu
France
Hospital Marie Lannelongue
ACTIVE_NOT_RECRUITING
Le Plessis-robinson
Hospital Paris Saint Joseph
RECRUITING
Paris
Germany
Fürst Stirum Klinik Bruchsal Hospital
RECRUITING
Bruchsal
University Clinic Essen-Hospital
RECRUITING
Essen
Klinikum der Ludwig-Maximilians-Universitat
RECRUITING
München
Poland
Uniwersyteckim Szpitalem Klinicznym w Poznaniu
RECRUITING
Poznan
Spain
Corporacio Sanitaria Parc Taulí, Barcelona
RECRUITING
Sabadell
Taiwan
China Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Thailand
Siriraj Hospital Department of Surgery
RECRUITING
Bangkok
Prince of Songkla University
RECRUITING
Hat Yai
Contact Information
Primary
Yumna Akhtar, MS
yumna.akhtar@bsci.com
651-399-6775
Backup
Kara Johnson
kara.johnson2@bsci.com
763-334-2963
Time Frame
Start Date: 2021-03-29
Estimated Completion Date: 2028-01
Participants
Target number of participants: 5000
Treatments
Clinical Cohort
All enrolled patients are included in the Clinical Cohort. Patients will complete assessments per standard of care through 2-year follow-up in Australia, Austria, Canada, France, Germany, Poland, Spain, Taiwan, Thailand, and the United States. Patients will complete assessments per standard of care through 5-year follow-up in China.
Outcomes Cohort
Patients at select sites will complete the Clinical Cohort standard of care assessments and additional assessments as part of the Outcomes Cohort, including Quality of Life questionnaires, six-minute walk test (6MWT), and Healthcare Utilization data collection.
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation