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

Recruiting

• Conditions: Peripheral Vascular Diseases

• Registration Number: NCT04674969
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Study Start: 2021-03-29
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-17
• Primary Completion: 2028-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

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; 🇺🇸 Saint Helena, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Christiana Hospital; 🇺🇸 Newport, Delaware, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Palm Beach Heart & Vascular, LLC; 🇺🇸 Boynton Beach, Florida, United States

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