Arterial Occlusive DiseasesREGALNCT03037411
A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries
An observational study of Arterial Occlusive Diseases and Atherosclerosis, run by Boston Scientific Corporation at 23 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases
- What is being tested?
- Peripheral stenting
- Type of treatment
- Medical device
- How many people
- 291 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 13 Dec 2016to 24 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Spain10 sites
Hospital Universitario de Burgos
Burgos, 09006
Hospital San Pedro de Alcántara
Cáceres, 10004
Hosp. Puerta del Mar
Cadiz
Hosp . Universitario de Guadalajara
Guadalajara, 19002
Hosp. Ntra Sra. del Rosario
Madrid, 28006
Hospital Clinico San Carlos
Madrid, 28040
Hosp. Complejo Hosp Universitario (CHUO)
Ourense
Hospital de Montecelo (Pontevedra EOXI)
Pontevedra, 30071
Hospital Parc Tauli
Sabadell
Foundation for the Aragonese Healthcare Research Institute
Zaragoza, 50009
Italy7 sites
ASL Asti
Asti, 14100
Policlinico Vittorio Emanuele
Catania
Policlinico di Monza
Monza
Policlinico Umberto I
Roma, 00161
L'Azienda sanitaira ASL Roma 1
Roma, 00193
IRCCS Policlinico San Donato
San Donato Milanese
Hospital Azienda Ospedaliera Universitaria Senese
Siena, 53100
Belgium3 sites
ZOL Genk
Genk, Limburg, 3600
CHU Sart Tilman
Liège
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Vlaams-Brabant, 3300
France2 sites
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble
Clinique Parly II
Le Chesnay, 78150
About this study
Official title: 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.
Read the 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.
- Being tested
- Peripheral stenting
- Keywords
- Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), Stenting, Paclitaxel, Health Economics
- Medical subject headings
- Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral stentingDevice
stent implantation during the index procedure
| Study group | Role | What they receive |
|---|---|---|
| ELUVIA stent implantation | Peripheral stenting Receives: Device: Peripheral stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline,12 and 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 12 and 24 months
Health Care Utilization
Changes in healthcare utilization over time
Measured: 1, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start13 Dec 2016
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Setacci, Principal investigator, Policlinico Le Scotte, Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037411
- Sponsor's protocol ID
- S2346
- Acronym
- REGAL
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2016
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Evaluation of the ELUVIA Drug Eluting Stent in All-Comers With Superficial Femoral Artery and Proximal Popliteal Artery Disease
- ClinicalTrials.gov ID
- NCT03037411
- Acronym / sponsor ID
- REGAL / S2346
- Keywords
- Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), Stenting, Paclitaxel, Health Economics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELUVIA stent implantation | – | Device: Peripheral stentingPeripheral stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral stentingstent implantation during the index procedure | Device | ELUVIA stent implantation |
Primary outcome
Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire.
Time frame: Baseline,12 and 24 months
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.
4 secondary outcomes
Number of Participants With Improvement on the Walking Impairment Questionnaire
Time frame: 12 and 24 months
Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement
Time frame: 12 and 24 months
Number of Participants With Hemodynamic Improvement
Time frame: 12 and 24 months
Health Care Utilization
Time frame: 1, 6, 12 and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Setacci principal investigator
Policlinico Le Scotte, Siena
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Occlusive Diseases and Atherosclerosis, run by Boston Scientific Corporation at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain, Italy, Belgium, France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. (time frame: Baseline,12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.