NCT04743180

European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: iVascular S.L.U. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.

Conditions

• Angioplasty
• Peripheral Arterial Disease
• Drug-eluting Balloon
• Femoral Artery
• Paclitaxel

Interventions

Type	Name	Description
DEVICE	LUMINOR© Paclitaxel eluting balloon	Patients will be treated with the Luminor paclitaxel eluting balloon

Timeline

• Start date: 2021-01-18
• Primary completion: 2022-06-01
• Completion: 2026-06-30
• First posted: 2021-02-08
• Last updated: 2021-02-11

Locations

15 sites across 1 country: France