CompletedNot Applicable

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

Austria, Belgium, France291 participantsStarted 2016-12-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

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

Timeframe: Baseline,12 and 24 months

Trial details

NCT IDNCT03037411

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-24

Results submitted2023-08-03

View on ClinicalTrials.gov More Arterial Occlusive Diseases trials