Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
- Conditions
- Peripheral Vascular Diseases
- Interventions
- Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
- Registration Number
- NCT04674969
- Lead Sponsor
- Boston Scientific Corporation
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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
- Life expectancy of <1 year
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Outcomes Cohort Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device. 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. Clinical Cohort Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device. 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.
- Primary Outcome Measures
Name Time Method Major Adverse Events 12 months Rate of MAEs, which include Target Lesion Revascularizations, Major Target Limb Amputations, and Deaths. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes.
Lesion Patency 12 months Lesion patency is determined by Duplex Ultrasound (Investigator and/or Core Lab assessed) and freedom from clinically-driven Target Lesion Revascularization. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (79)
St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
PIH Health Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Cedars - Sinai Medical Center
🇺🇸Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Sutter Medical Center, Sacramento
🇺🇸Sacramento, California, United States
Adventist Health St Helena Hospital
🇺🇸Saint Helena, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Christiana Hospital
🇺🇸Newport, Delaware, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Palm Beach Heart & Vascular, LLC
🇺🇸Boynton Beach, Florida, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Rush University
🇺🇸Chicago, Illinois, United States
St. John's Hospital/ Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
St. Joseph Hospital/Dupont Hospital
🇺🇸Fort Wayne, Indiana, United States
Ascension St. Vincent's Hospital
🇺🇸Indianapolis, Indiana, United States
CIS Clinical Research Corporation
🇺🇸Houma, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸Kenner, Louisiana, United States
Cardiovascular Institute of the South
🇺🇸Lafayette, Louisiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mercy Hospital (Allina Health)
🇺🇸Coon Rapids, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Deborah Heart & Lung Center
🇺🇸Brown Mills, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
North Shore University Hospital/Northwell Health
🇺🇸Manhasset, New York, United States
New York University Medical Center
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
Memorial Sloan Kettering Hospital
🇺🇸New York, New York, United States
Weill Cornell Medicine/New York-Presbyterian Hospital
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Rex UNC Health (NC Heart and Vascular Research, LLC)
🇺🇸Raleigh, North Carolina, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Premier Cardiovascular Institute
🇺🇸Dayton, Ohio, United States
Ascension St. John Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
Hospital University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Monument Health Rapid City Hospital, Inc.
🇺🇸Rapid City, South Dakota, United States
Seton Medical Center
🇺🇸Austin, Texas, United States
The University of Texas, Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
HeartPlace P.A.
🇺🇸Plano, Texas, United States
Inova Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
UW Medicine - Harborview Medical Center
🇺🇸Seattle, Washington, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, Australia
Medizinische Univ.-Kliniken Graz
🇦🇹Graz, Austria
Peter Lougheed Centre-Hospital
🇨🇦Calgary, Alberta, Canada
CHUS - Hotel Dieu
🇨🇦Sherbrooke, Quebec, Canada
Beijing Anzhen Hospital of the Capital University of Medical Sciences
🇨🇳Chaoyang, Beijing, China
China-Japan Friendship Hospital
🇨🇳Chaoyang, Beijing, China
Xuanwu Hospital Capital Medical University
🇨🇳Xicheng, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, 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, China
Shanghai Changhai Hospital
🇨🇳Yangpu, Shanghai, 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, 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
🇵🇱Poznań, Poland
Corporacio Sanitaria Parc TaulÃ, Barcelona
🇪🇸Sabadell, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Siriraj Hospital Department of Surgery
🇹ðŸ‡Bangkok, Thailand
Prince of Songkla University
🇹ðŸ‡Hat Yai, Thailand