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

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Intervention / Treatment: Device: Peripheral stenting

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 Type: Observational
• Enrollment (Actual): 291

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medizinische Universität Graz
• Belgium
  • Liège, Belgium
    • Chu Sart Tilman
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • ZOL GENK
  • Vlaams-Brabant
    • Tienen, Vlaams-Brabant, Belgium, 3300
      • Regionaal Ziekenhuis Heilig Hart Tienen
• France
  • Grenoble, France
    • Centre Hospitalier Universitaire Grenoble-Alpes
  • Le Chesnay, France, 78150
    • Clinique Parly II
• Italy
  • Asti, Italy, 14100
    • ASL Asti
  • Catania, Italy
    • Policlinico Vittorio Emanuele
  • Monza, Italy
    • Policlinico di Monza
  • Roma, Italy, 00161
    • Policlinico Umberto I
  • Roma, Italy, 00193
    • L'Azienda sanitaira ASL Roma 1
  • San Donato Milanese, Italy
    • IRCCS Policlinico San Donato
  • Siena, Italy, 53100
    • Hospital Azienda Ospedaliera Universitaria Senese
• Spain
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Cadiz, Spain
    • Hosp. Puerta Del Mar
  • Cáceres, Spain, 10004
    • Hospital San Pedro de Alcántara
  • Guadalajara, Spain, 19002
    • Hosp . Universitario de Guadalajara
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28006
    • Hosp. Ntra Sra. del Rosario
  • Ourense, Spain
    • Hosp. Complejo Hosp Universitario (CHUO)
  • Pontevedra, Spain, 30071
    • Hospital de Montecelo (Pontevedra EOXI)
  • Sabadell, Spain
    • Hospital Parc Tauli
  • Zaragoza, Spain, 50009
    • Foundation for the Aragonese Healthcare Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ELUVIA stent implantation; Peripheral stenting	Device: Peripheral stenting; stent implantation during the index procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improvement on the Walking Impairment Questionnaire	Improvement was calculated by comparing the scores from 12- and 24-Months to the baseline scores and presenting the number of participants that showed improvement at 12- and 24-Months. The WIQ measures the improvement as reported by participants in their walking distance, walking speed, stair-climbing ability and improvement in their PAD symptoms pre-procedure (baseline) compared to 12 months and compared to 24 months. The improvement at those time points is measured as percent improvement.	12 and 24 months
Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement	The Rutherford Classification describes the different stages of peripheral artery disease (PAD) from a score of 0 (no PAD) to 6 (critical limb ischemia with major tissue loss). The percentages represent the percent of participants that had sustained clinical improvement from baseline to 12 months and baseline to 24 months. Sustained clinical improvement means their Rutherford Class improved by one or more categories compared with baseline. Number of participants with improved Rutherford Classification at 12- and 24-Months when compared to baseline. Primary Sustained Clinical Improvement is improvement in Rutherford Classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR). Secondary Sustained Clinical Improvement is improvement in Rutherford classification of one or more categories as compared to baseline including those participants with repeat TLR.	12 and 24 months
Number of Participants With Hemodynamic Improvement	Number of participants with improvement in Ankle-Brachial Index (ABI) at 12- and 24-Months compared to baseline. Hemodynamic Improvement is defined as an increase in ABI of >= 0.10 or to an ABI >= 0.90 as compared to baseline without the need for repeat TLR. The ABI measures the arterial pressure in the leg compared to the arterial pressure in the arm. The higher the value, the better the blood flow. Improvement is defined as an increase in the ABI by greater than or equal to 0.10 compared with baseline or to an ABI greater than or equal to 0.90. The percentages in the table represent the patients that demonstrated an improvement in their ABI from baseline to 12 months and baseline to 24-months.	12 and 24 months
Health Care Utilization	Changes in healthcare utilization over time	1, 6, 12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Technical Success of the Stenting Procedure	Number of participants that successfully received Eluvia stent. Technical success defined as implanted and achieving residual angiographic stenosis no greater than 30% assessed visually.	During stenting procedure
Number of Participants With Procedural Success of the Stenting Procedure	Number of participants with successful procedures. Procedural success defined as technical success with no major adverse events (MAEs) noted within 24 hours of the stenting procedure.	within 24 hours of stenting procedure
Number of Participants With a Major Adverse Event (MAE)	Number of participants with Clinical Events Committee (CEC) adjudicated MAEs at 12- and 24-Months cumulatively. The MAEs are defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate. A participant can be present in more than one sub-category.	12 and 24 months
Percentage of Participants With Primary Patency at 12- and 24-Months Post Procedure	The numbers represent the percentage of patients that were event free at 12 and 24 months (i.e. didn't have a TLR).	12 and 24 months
Number of Participants With a Clinically-driven Target Lesion Revascularization (TLR)	The cumulative number of participants that received a clinically-driven target lesion revascularization after the stenting procedure.	12 and 24 months
Number of Participants With a Clinically-driven Target Vessel Revascularization (TVR)	The cumulative number of participants that received a clinically-driven target vessel revascularization after the stenting procedure.	12 and 24 months
Participant Distribution on the Rutherford Classification at Baseline, 12-, and 24- Month	Rutherford Classification: 0. Asymptomatic - Normal Treadmill /stress test; Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise <50mm Hg, but >25 mm Hg less than blood pressure (BP); Moderate claudication - Between categories 1 and 3; Severe claudication - Cannot complete treadmill exercise and AP after exercise <50 mm Hg; Ischemic rest pain - Resting AP <40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) <30 mm Hg; Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal edema - Resting AP <60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP <40 mm Hg; Major tissue loss-extending above MT level - Same as Category 5	Baseline, 12 and 24 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Carlo Setacci, Policlinico Le Scotte, Siena

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2016
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimated): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Atherosclerosis; Paclitaxel; Stenting; Superficial Femoral Artery (SFA); Proximal Popliteal Artery (PPA); Health Economics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Arterial Occlusive Diseases
• Other Study ID Numbers: S2346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED