RecruitingNCT04743180

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


Sponsor

iVascular S.L.U.

Enrollment

500 participants

Start Date

Jan 18, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called LUMINOR© Paclitaxel eluting balloon for people with angioplasty, drug-eluting balloon, and other related conditions. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELUMINOR© Paclitaxel eluting balloon

Patients will be treated with the Luminor paclitaxel eluting balloon


Locations(15)

Centre Hospitalier Universitaire Pellegrin

Bordeaux, New Aquitaine, France

Clinique Générale Annecy

Annecy, France

Clinique Rhône Durance

Avignon, France

Centre hospitalier de la Côte Basque

Bayonne, France

Polyclinic Bordeaux Nord Aquitaine

Bordeaux, France

Hôpital Ambroise Paré

Boulogne-Billancourt, France

Centre Hospitalier Régional Universitaire Morvan de Brest

Brest, France

CHRU Lille

Lille, France

Clinic Mutualiste Porte de L'Orient

Lorient, France

CHU Timone Marseille

Marseille, France

CH Layné

Mont-de-Marsan, France

Hôpital Privé des Franciscaines

Nîmes, France

Fondation Hôpital St Joseph

Paris, France

Clinique Saint Jean

Saint-Jean-de-Védas, France

Clinique Rhéna

Strasbourg, France

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NCT04743180


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