Status: Recruiting
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
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.
Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: iVascular S.L.U.Updated: Feb 11, 2021Locations: 15Duration: 60 Months
Eligibility criteria
≥ 18 years of age [+10]
Women who are pregnant, lactating, or planning on becoming pregnant or men inten... [+5]