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

NCT04674969 · tracked via the Priya Life Science Israel tracker

Sponsor

Boston Scientific Corporation

Phase

Observational

Started

2021-03-29

Last updated

2026-10-16

Condition(s) studied

Peripheral Vascular Diseases

Investigational drug(s) / intervention(s)

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (86)

Facility	City	Region	Status
St. Bernard's Medical Center	Jonesboro	Arkansas	Recruiting
PIH Health Good Samaritan Hospital	Los Angeles	California	Recruiting
Cedars - Sinai Medical Center	Los Angeles	California	Recruiting
Ronald Reagan UCLA Medical Center	Los Angeles	California	Withdrawn
Sutter Medical Center, Sacramento	Sacramento	California	Completed
Adventist Health St Helena Hospital	St. Helena	California	Recruiting
Yale University School of Medicine	New Haven	Connecticut	Recruiting
Christiana Hospital	Newport	Delaware	Recruiting
Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
Palm Beach Heart & Vascular, LLC	Boynton Beach	Florida	Withdrawn
Morton Plant Mease Healthcare System	Clearwater	Florida	Recruiting
Tallahassee Memorial Hospital	Tallahassee	Florida	Recruiting
Emory University Hospital	Atlanta	Georgia	Recruiting
South Georgia Medical Center	Valdosta	Georgia	Recruiting
Rush University	Chicago	Illinois	Recruiting
St. John's Hospital/ Prairie Education and Research Cooperative	Springfield	Illinois	Recruiting
St. Joseph Hospital/Dupont Hospital	Fort Wayne	Indiana	Withdrawn
Ascension St. Vincent's Hospital	Indianapolis	Indiana	Recruiting
CIS Clinical Research Corporation	Houma	Louisiana	Completed
Ochsner Clinic Foundation	Kenner	Louisiana	Recruiting
Cardiovascular Institute of the South	Lafayette	Louisiana	Withdrawn
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
Mercy Hospital (Allina Health)	Coon Rapids	Minnesota	Active Not Recruiting
North Mississippi Medical Center	Tupelo	Mississippi	Recruiting
Deborah Heart & Lung Center	Browns Mills	New Jersey	Active Not Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	Recruiting
Newark Beth Israel Medical Center	Newark	New Jersey	Recruiting
Buffalo General Hospital	Buffalo	New York	Recruiting
North Shore University Hospital/Northwell Health	Manhasset	New York	Active Not Recruiting
New York University Medical Center	New York	New York	Recruiting
Columbia University	New York	New York	Recruiting
Mount Sinai	New York	New York	Recruiting
Memorial Sloan Kettering Hospital	New York	New York	Recruiting
Weill Cornell Medicine/New York-Presbyterian Hospital	New York	New York	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
Rex UNC Health (NC Heart and Vascular Research, LLC)	Raleigh	North Carolina	Recruiting
University Hospitals of Cleveland	Cleveland	Ohio	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Premier Cardiovascular Institute	Dayton	Ohio	Completed
Ascension St. John Clinical Research Institute	Tulsa	Oklahoma	Recruiting

+ 46 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04674969 on ClinicalTrials.gov ↗ ← All trials in Israel