NCT03037411

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 291 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Arterial Occlusive Diseases
• Atherosclerosis
• Vascular Diseases
• Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	Peripheral stenting	stent implantation during the index procedure

Timeline

• Start date: 2016-12-13
• Primary completion: 2022-03-24
• Completion: 2022-03-24
• First posted: 2017-01-31
• Last updated: 2026-03-31
• Results posted: 2026-03-31

Locations

23 sites across 5 countries: Austria, Belgium, France, Italy, Spain