NCT04674969

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Vascular Diseases

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2021-03-29
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2020-12-19
• Last updated: 2026-03-12

Locations

79 sites across 11 countries: United States, Australia, Austria, Canada, China, France, Germany, Poland, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated device study