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ELEGANCE Registry: Real-World Treatment of Peripheral Vascular Disease

This study, called the ELEGANCE Registry, is looking at how well Boston Scientific's drug-eluting devices, like the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and the ELUVIA™ Drug-Eluting Vascular Stent System, work in real-world situations for people with peripheral vascular disease (PVD). PVD affects blood vessels outside of the heart and brain. The study wants to include people who haven't been part of past PVD trials. To join, you must be 18 or older and be treated with one of these specific Boston Scientific devices. The researchers will track major problems and how well the treated blood vessels stay open for 12 months. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving specific treatments. It's a global study aiming to include 5000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to track major adverse events and how well their blood vessels remain open.

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NCT04674969

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

Recruiting
Not specifiedAges 18+Observational
Boston Scientific Corporation
~5,000 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.

At a glance

Recruiting sites
55 of 82 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major Adverse Events
Measured over 12 months
+1 more outcome measured

Conditions

Peripheral Vascular Diseases

Explore related trials

Peripheral Vascular Disorder

Where it's being run

82 sites across 45 states
New York7
California5
Texas5
Louisiana3
New Jersey3
Ohio3
Pennsylvania3
Beijing Municipality3

Who to contact

Yumna Akhtar, MS
[email protected]
651-399-6775
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Eligibility criteria

Inclusion

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

Life expectancy of \<1 year

What this trial measures

  • Major Adverse Events12 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 Patency12 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.