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.
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 Type
OBSERVATIONAL
Enrollment
5,000
Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System
Major Adverse Events
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.
Time frame: 12 months
Lesion Patency
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.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Bernard's Medical Center
Jonesboro, Arkansas, United States
RECRUITINGPIH Health Good Samaritan Hospital
Los Angeles, California, United States
RECRUITINGCedars - Sinai Medical Center
Los Angeles, California, United States
RECRUITINGRonald Reagan UCLA Medical Center
Los Angeles, California, United States
WITHDRAWNSutter Medical Center, Sacramento
Sacramento, California, United States
COMPLETEDAdventist Health St Helena Hospital
St. Helena, California, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGChristiana Hospital
Newport, Delaware, United States
RECRUITINGWashington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGPalm Beach Heart & Vascular, LLC
Boynton Beach, Florida, United States
WITHDRAWN...and 69 more locations