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Drug-Eluting Device
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE Trial)
N/A
Recruiting
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Peripheral Vascular Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Lesion Patency
Major Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Outcomes CohortExperimental Treatment1 Intervention
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.
Group II: Clinical CohortExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
745 Previous Clinical Trials
852,598 Total Patients Enrolled