Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
ELEGANCE
1 other identifier
observational
5,000
10 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 21, 2026
April 1, 2026
6.8 years
December 1, 2020
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Major Adverse Events
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.
12 months
Lesion Patency
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.
12 months
Study Arms (2)
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.
Interventions
Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System
Eligibility Criteria
The intended population for the ELEGANCE Registry are real-world patients who are treated with commercially available BSC drug-eluting devices marketed for treatment of lesions located in the peripheral vasculature. Efforts will be made to include study centers with diverse patient populations in order to enroll populations previously not represented in PVD trials.
You may qualify if:
- 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
You may not qualify if:
- Life expectancy of \<1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
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
Related Publications (1)
Secemsky EA, Giri J, Brodmann M, Goueffic Y, Fu W, Greenberg-Worisek AJ, Jaff MR, Kirksey L, Kohi MP. Implementing methods in the ELEGANCE registry to increase diversity in clinical research. J Vasc Surg. 2024 Jan;79(1):136-145.e3. doi: 10.1016/j.jvs.2023.08.131. Epub 2023 Sep 22.
PMID: 37742734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 19, 2020
Study Start
March 29, 2021
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04