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

Recruiting
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
Inclusion Criteria
  • 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
Exclusion Criteria
  • Life expectancy of <1 year

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Outcomes CohortAny 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 CohortAny 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
NameTimeMethod
Major Adverse Events12 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 Patency12 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
NameTimeMethod

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

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St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
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