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

Boston Scientific

Status: Enrolling

Conditions: Peripheral Vascular Diseases

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04674969

S2444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

5,000 participants in 2 patient groups

Clinical Cohort

Description:

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.

Treatment:

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

Outcomes Cohort

Description:

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.

Treatment:

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