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NCT04674969 Clinical Trial

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

Peripheral Vascular Diseases Clinical Trial

— ELEGANCE  

Official title:
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04674969
Other study ID # S2444
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2021
Est. completion date January 2028

Study information
Verified date June 2024
Source Boston Scientific Corporation
Contact Yumna Akhtar, MS
Phone 651-399-6775
Email yumna.akhtar@bsci.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date January 2028
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System

Locations
Country Name City State
Australia Royal Perth Hospital Perth Western Australia
Australia Royal North Shore Hospital St. Leonards
Austria Medizinische Univ.-Kliniken Graz Graz
Canada Peter Lougheed Centre-Hospital Calgary Alberta
Canada CHUS Sherbrooke Quebec
China Beijing Anzhen Hospital of the Capital University of Medical Sciences Chaoyang Beijing
China China-Japan Friendship Hospital Chaoyang Beijing
China The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China Zhongshan University No.1 Hospital Guangzhou Guangdong
China Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine Huangpu Shanghai
China Affiliated Hospital of Medical College Qingdao University Qingdao Shandong
China Shanghai Zhongshan Hospital Shanghai Xuhui District
China Shanxi Bethune Hospital Taiyuan Shanxi
China First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an Shanxi
China Xuanwu Hospital Capital Medical University Xicheng Beijing
China Shanghai Changhai Hospital Yangpu Shanghai
France Hospital Marie Lannelongue Le Plessis-Robinson
France Hospital Paris Saint Joseph Paris
Germany Fürst Stirum Klinik Bruchsal Hospital Bruchsal
Germany University Clinic Essen-Hospital Essen
Germany Klinikum der Ludwig-Maximilians-Universitat München
Poland Uniwersyteckim Szpitalem Klinicznym w Poznaniu Poznan
Spain Hospital Parc Tauli Sabadell
Taiwan China Medical University Hospital Taichung
Taiwan National Taiwan University Hospital Taipei City
Thailand Siriraj Hospital Department of Surgery Bangkok
Thailand Prince of Songkla University Hat Yai
United States Ascension Seton Medical Center Austin Austin Texas
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Palm Beach Heart & Vascular, LLC Boynton Beach Florida
United States Deborah Heart & Lung Center Browns Mills New Jersey
United States Buffalo General Hospital Buffalo New York
United States Medical University of South Carolina Charleston South Carolina
United States Rush University Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Mercy Hospital (Allina Health) Coon Rapids Minnesota
United States The University of Texas, Southwestern Medical Center Dallas Texas
United States Premier Cardiovascular Institute Dayton Ohio
United States Duke University Medical Center Durham North Carolina
United States Inova Fairfax Hospital Fairfax Virginia
United States St. Joseph Hospital/Dupont Hospital Fort Wayne Indiana
United States Hackensack University Medical Center Hackensack New Jersey
United States Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania
United States CIS Clinical Research Corporation Houma Louisiana
United States Ascension St. Vincent's Hospital Indianapolis Indiana
United States St. Bernard's Medical Center Jonesboro Arkansas
United States Ochsner Health Kenner Louisiana
United States Cardiovascular Institute of the South Lafayette Louisiana
United States Cedars Sinai Los Angeles California
United States PIH Health Good Samaritan Hospital Los Angeles California
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States Texas Tech University Health Sciences Center Lubbock Texas
United States North Shore University Hospital/Northwell Health Manhasset New York
United States Yale University School of Medicine New Haven Connecticut
United States Columbia University New York New York
United States Memorial Sloan Kettering Hospital New York New York
United States Mount Sinai New York New York
United States New York University Medical Center New York New York
United States Weill Cornell Medicine/New York-Presbyterian Hospita New York New York
United States Robert Wood Johnson/Newark Beth Israel Medical Center Newark New Jersey
United States Christiana Hospital Newport Delaware
United States Hospital University of Pennsylvania Philadelphia Pennsylvania
United States HeartPlace Plano Texas
United States The Miriam Hospital Providence Rhode Island
United States Rex UNC Health (NC Heart and Vascular Research, LLC) Raleigh North Carolina
United States Monument Health Rapid City Hospital, Inc. Rapid City South Dakota
United States Sutter Medical Center, Sacramento Sacramento California
United States Adventist Health St Helena Hospital Saint Helena California
United States UW Medicine - Harborview Medical Center Seattle Washington
United States St. John's Hospital/ Prairie Education and Research Cooperative Springfield Illinois
United States Tallahassee Memorial Hospital Tallahassee Florida
United States Ascension St. John Clinical Research Institute Tulsa Oklahoma
United States North Mississippi Medical Center Tupelo Mississippi
United States South Georgia Medical Center Valdosta Georgia
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  China,  France,  Germany,  Poland,  Spain,  Taiwan,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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