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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical Cohort<br>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. | Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.<br>* Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System<br>|
| Outcomes Cohort<br>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. | Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.<br>* Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months |