Recruiting

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

Sponsor:

Boston Scientific Corporation

Code:

NCT04674969

Conditions

Peripheral Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Peripheral Vascular Diseases

Study ID

NCT04674969

Start date

Mar 29, 2021

Status verified date

Aug, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Primary outcome measure

Major Adverse Events [ Time Frame: 12 months ]
Lesion Patency [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Yumna Akhtar, MS

651-399-6775 yumna.akhtar@bsci.com

Kara Johnson

763-334-2963 kara.johnson2@bsci.com

Locations

St. Bernard's Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Principal Investigator:

Max Arroyo

PIH Health Good Samaritan Hospital

Recruiting

Los Angeles, California, United States, 90017

Principal Investigator:

Guy Mayeda

Cedars - Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Suhail Dohad

Adventist Health St Helena Hospital

Recruiting

St. Helena, California, United States, 94574

Principal Investigator:

Leonardo Clavijo

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

Cassius Ochoa Chaar

Christiana Hospital

Recruiting

Newport, Delaware, United States, 19718

Principal Investigator:

Daniel Leung

Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

Nelson Bernardo

Tallahassee Memorial Hospital

Recruiting

Tallahassee, Florida, United States, 32308

Principal Investigator:

William Dixon

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

Manuel Garcia-Toca

South Georgia Medical Center

Recruiting

Valdosta, Georgia, United States, 31602

Principal Investigator:

David Hardy

Rush University

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Kumar Madassery

St. John's Hospital/ Prairie Education and Research Cooperative

Recruiting

Springfield, Illinois, United States, 62701

Principal Investigator:

Avinash Murthy

Ascension St. Vincent's Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Principal Investigator:

Kannan Natarajan

Ochsner Clinic Foundation

Recruiting

Kenner, Louisiana, United States, 70121

Principal Investigator:

George Yousef

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Eric Secemsky

North Mississippi Medical Center

Recruiting

Tupelo, Mississippi, United States, 38804

Principal Investigator:

Barry Bertolet

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator:

David O'Connor

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Principal Investigator:

John Shao

Buffalo General Hospital

Recruiting

Buffalo, New York, United States, 55313

Principal Investigator:

Sonya Noor

New York University Medical Center

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Anvar Babaev

Columbia University

Recruiting

New York, New York, United States, 10027

Principal Investigator:

Sahil Parikh

Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Kirema Garcia-Reyes

Memorial Sloan Kettering Hospital

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Yolanda Bryce

Weill Cornell Medicine/New York-Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Brian DeRubertis

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Chandler Long

Rex UNC Health (NC Heart and Vascular Research, LLC)

Recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator:

Ravish Sachar

University Hospitals of Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Jun Li

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Sean Lyden

Ascension St. John Clinical Research Institute

Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator:

Nicholas Hanna

Hospital University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Grace Wang

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Dawn Salvatore

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Principal Investigator:

Peter Soukas

Seton Medical Center

Recruiting

Austin, Texas, United States, 78705

Principal Investigator:

Peter Monteleone

The University of Texas, Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

Michael Siah

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Jayer Chung

HeartPlace P.A.

Recruiting

Plano, Texas, United States, 75075

Principal Investigator:

Vijay Ramanath

Inova Fairfax Hospital

Recruiting

Fairfax, Virginia, United States, 22042

Principal Investigator:

Jonathan Keung

UW Medicine - Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Elina Quiroga

Peter Lougheed Centre-Hospital

Recruiting

Calgary, Alberta, Canada

Principal Investigator:

Ani Mirakhur

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-08-19.