RecruitingNCT04674969

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

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

Sponsor

Boston Scientific Corporation

Enrollment

5,000 participants

Start Date

Mar 29, 2021

Study Type

OBSERVATIONAL

Conditions

Peripheral Vascular Diseases

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a real-world registry tracking outcomes in patients who are treated with drug-eluting devices made by Boston Scientific for peripheral artery disease (PAD) — conditions affecting the arteries in the legs, arms, and other areas outside the heart. Drug-eluting devices release medication locally to prevent the treated artery from re-narrowing (restenosis) after the procedure. By collecting real-world data across many patients and clinical settings, researchers aim to understand how well these devices work in everyday practice, including in patients who may not have qualified for the original clinical trials. This is an observational registry — participants receive whatever treatment their doctor has already planned and are simply monitored over time for outcomes. You may be eligible if: - You are 18 years or older - You have provided informed consent for data collection - You are receiving treatment with a commercially available Boston Scientific drug-eluting device for peripheral vascular disease as part of your standard medical care You may NOT be eligible if: - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAny 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(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

St. Helena, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Christiana Hospital

Newport, Delaware, United States

Washington Hospital Center

Washington D.C., 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

Browns 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