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

NCT03037411 | Completed Results

• 1 other identifier: S2346
• Study Type: observational
• Target: 291
• Locations: 5 countries
• Sites: 23

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.

Conditions

Arterial Occlusive Diseases; Atherosclerosis; Arteriosclerosis; Vascular Diseases

Keywords

Atherosclerosis; Superficial Femoral Artery (SFA); Proximal Popliteal Artery (PPA); Stenting; Paclitaxel; Health Economics

Outcome Measures

Primary Outcomes (1)

• Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire.

  The EQ-5D assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) of health-related quality of life responses assigned by the participants. The values are anchored at 1 (best) to 0 (worst). The vales for the visual analog score takes values from 100 (best) to 0 (worst). The index value is comparable across the baseline, 12- and 24-Months timepoints.

  Baseline,12 and 24 months

Secondary Outcomes (4)

• Number of Participants With Improvement on the Walking Impairment Questionnaire

  12 and 24 months

• Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement

  12 and 24 months

• Number of Participants With Hemodynamic Improvement

  12 and 24 months

• Health Care Utilization

  1, 6, 12 and 24 months

Other Outcomes (7)

• Number of Participants With Technical Success of the Stenting Procedure

  During stenting procedure

• Number of Participants With Procedural Success of the Stenting Procedure

  within 24 hours of stenting procedure

• Number of Participants With a Major Adverse Event (MAE)

  12 and 24 months

Study Arms (1)

ELUVIA stent implantation

Peripheral stenting

Device: Peripheral stenting

Interventions

Peripheral stenting DEVICE

stent implantation during the index procedure

ELUVIA stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Intended population for the REGAL study are 'real world'-patients with symptomatic de-novo, restenotic, or (re)occluded lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (23)

Medizinische Universität Graz

Graz, Austria

Location

ZOL Genk

Genk, Limburg, 3600, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

Location

CHU Sart Tilman

Liège, Belgium

Location

Centre Hospitalier Universitaire Grenoble-Alpes

Grenoble, France

Location

Clinique Parly II

Le Chesnay, 78150, France

Location

ASL Asti

Asti, 14100, Italy

Location

Policlinico Vittorio Emanuele

Catania, Italy

Location

Policlinico di Monza

Monza, Italy

Location

Policlinico Umberto I

Roma, 00161, Italy

Location

L'Azienda sanitaira ASL Roma 1

Roma, 00193, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Location

Hospital Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hosp. Puerta del Mar

Cadiz, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10004, Spain

Location

Hosp . Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Hosp. Ntra Sra. del Rosario

Madrid, 28006, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hosp. Complejo Hosp Universitario (CHUO)

Ourense, Spain

Location

Hospital de Montecelo (Pontevedra EOXI)

Pontevedra, 30071, Spain

Location

Hospital Parc Tauli

Sabadell, Spain

Location

Foundation for the Aragonese Healthcare Research Institute

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Arteriosclerosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

• Title: Bryan Arebalo
• Organization: Boston Scientific

bryan.arebalo@bsci.com

+1 949-241-4300

Study Officials

• Carlo Setacci

  Policlinico Le Scotte, Siena

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 31, 2017
• Study Start: December 13, 2016
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Locations

AU (1); ES (10); FR (2); IT (7); BE (3)