Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
- Conditions
- Peripheral Vascular Diseases
- Interventions
- Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
- Registration Number
- NCT04674969
- Lead Sponsor
- Boston Scientific Corporation
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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
- Life expectancy of <1 year
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Outcomes Cohort Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device. 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. Clinical Cohort Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device. 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (79)
St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
PIH Health Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Cedars - Sinai Medical Center
🇺🇸Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Sutter Medical Center, Sacramento
🇺🇸Sacramento, California, United States
Adventist Health St Helena Hospital
🇺🇸Saint Helena, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Christiana Hospital
🇺🇸Newport, Delaware, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Palm Beach Heart & Vascular, LLC
🇺🇸Boynton Beach, Florida, United States
Scroll for more (69 remaining)St. Bernard's Medical Center🇺🇸Jonesboro, Arkansas, United States