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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• 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 sites (83)

+ 43 more sites — see the full list on the official registry below.