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

Completed

• Conditions: Vascular Diseases; Arterial Occlusive Diseases; Atherosclerosis; Arteriosclerosis
• Interventions: Device: Peripheral stenting

• Registration Number: NCT03037411
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12-13
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2022-03-24
• Study Completion: 2022-03-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

1. Subjects age 18 and older
2. 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
3. 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

1. Subject is pregnant or planning to become pregnant during the course of the study
2. 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)
3. Known allergy to the ELUVIA stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed)
4. 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ELUVIA stent implantation	Peripheral stenting	Peripheral stenting

Primary Outcome Measures

Name	Time	Method
Health care costs	Index Procedure, 1, 6, 12 and 24 months	Health care costs at index procedure and changes in health care costs from baseline

Secondary Outcome Measures

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

Trial Locations

Locations (23)

Medizinische Universität Graz; 🇦🇹 Graz, Austria

ZOL Genk; 🇧🇪 Genk, Limburg, Belgium

Regionaal Ziekenhuis Heilig Hart Tienen; 🇧🇪 Tienen, Vlaams-Brabant, Belgium

CHU Sart Tilman; 🇧🇪 Liège, Belgium

Centre Hospitalier Universitaire Grenoble-Alpes; 🇫🇷 Grenoble, France

Clinique Parly II; 🇫🇷 Le Chesnay, France

ASL Asti; 🇮🇹 Asti, Italy

Policlinico Vittorio Emanuele; 🇮🇹 Catania, Italy

Policlinico di Monza; 🇮🇹 Monza, Italy

Policlinico Umberto I; 🇮🇹 Roma, Italy

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