A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries

Study Overview
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Brief Summary
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The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

Detailed Description
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A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries. The objective of the study is to collect additional data including health economics data to support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Official Title
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A Real World Evaluation of the ELUVIA Drug Eluting Stent in All-Comers With Superficial Femoral Artery and Proximal Popliteal Artery Disease

Conditions
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Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis

Intervention / Treatment
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* Device: Peripheral stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18 and older Subject is willing and able to provide written consent before any study-specific test or procedure is performed and agrees to attend all follow-up visits De novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries, with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment Exclusion Criteria: Subject is pregnant or planning to become pregnant during the course of the study Life expectancy of less than 1 year (which is defined as documented life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical follow-up, limit the subject's compliance with the standard of care follow-up, or impact the scientific integrity of the trial) Known allergy to the ELUVIA stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed) Subject enrolled in an investigational study that has not reached primary endpoint at the time of enrollment or that clinically interferes with the current study assessments (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)

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 |
| --- | --- |
| ELUVIA stent implantation<br>Peripheral stenting | Device: Peripheral stenting<br>* stent implantation during the index procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care costs | Health care costs at index procedure and changes in health care costs from baseline | Index Procedure, 1, 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Improvement | Change in EQ-5D-5L™ from baseline | 1, 6, 12 and 24 months | 
| Walking Improvement | Change in Walking Impairment Questionnaire (WIQ) from baseline | 1, 6, 12 and 24 months | 
| Rate of Primary and Secondary Sustained Clinical Improvement | Changes in Rutherford Classification from baseline | 1, 6, 12 and 24 months | 
| Rate of Hemodynamic Improvement | Changes in in Ankle-Brachial Index (ABI) from baseline | 1, 6, 12 and 24 months | 
| Health care utilization | Changes in healthcare utilization over time | 1, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), Stenting, Paclitaxel, Health Economics