CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 291 enrolled
Drug / intervention
Peripheral stentingdevice
Likely dose
ELUVIA drug-eluting stent system implanted during index procedureAI-extracted
Key inclusion· 3
  • ✓Age 18 years or older
  • ✓De novo, restenotic, or (re)occluded lesions in native femoro-popliteal arteries with reference vessel diameter 4.0–6.0 mm, suitable for endovascular treatment
  • ✓Willing and able to provide written informed consent and attend all follow-up visits
Key exclusion· 4
  • ✕Pregnant or planning to become pregnant during the study
  • ✕Life expectancy less than 1 year due to medical comorbidities that would limit ability to participate in follow-up, comply with standard care, or maintain scientific integrity
  • ✕Known allergy to ELUVIA stent system or any of its components, concomitant medication, or contrast agents (unless medically manageable)
  • ✕Concurrent enrollment in another investigational study at primary endpoint or study that clinically interferes with current assessments

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03037411
NCT03037411N/ACompleted
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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

Boston Scientific Corporation·observational·Posted Jan 31, 2017·Updated Mar 31, 2026

In Brief

An observational study evaluating Peripheral stenting for Arterial Occlusive Diseases and 3 related conditions. Completed, enrolled 291 participants across 23 sites in 5 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsArterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
CountriesAustria, Belgium, France, Italy, Spain
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartDec 13, 2016
Primary CompletionMar 24, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.4 years ago

Interventions

Peripheral stentingdevice

stent implantation during the index procedure