N/A
Completed N=291
A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries
Arterial Occlusive Diseases · Atherosclerosis · Vascular Diseases · Arteriosclerosis
Source: ClinicalTrials.gov NCT03037411 ↗
Enrolled (actual)
291
Serious AEs
29.9%
Results posted
Mar 2026
Primary outcomePrimary: Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. — 0.7; 0.9; 0.8; 60.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. |
0.7; 0.9; 0.8; 60.9; 73.4; 72.0 | — |
| SECONDARY Number of Participants With Improvement on the Walking Impairment Questionnaire |
166; 156; 158; 140; 132; 116 | — |
| SECONDARY Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement |
187; 165; 203; 185 | — |
| SECONDARY Number of Participants With Hemodynamic Improvement |
137; 102; 146; 114 | — |
| SECONDARY Health Care Utilization |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03037411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.