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 European registry is tracking 5-year outcomes of patients treated with the LUMINOR Drug-Eluting Balloon (DEB) for blockages in the superficial femoral artery (SFA) and popliteal artery — the main arteries supplying blood to the leg. Peripheral artery disease (PAD) in these arteries causes pain when walking (claudication) or even at rest, and can threaten limb survival in severe cases. Drug-eluting balloons are inflated inside the blocked artery and release a drug (paclitaxel) that prevents the artery from narrowing again. The registry collects real-world data from multiple European centers over 5 years to assess how well the LUMINOR DEB works in clinical practice — measuring outcomes like freedom from target lesion revascularization, amputation rates, and walking ability. This long-term data is important for establishing evidence around this device. You may be eligible if: - You are 18 or older - You have significant (70%+ stenosis or occlusion) of a native superficial femoral or popliteal artery - You have claudication or more severe leg symptoms (Rutherford categories 2–5) - You have had successful guidewire crossing and balloon pre-dilation of the lesion - You are willing to give informed consent and attend 5 years of follow-up You may NOT be eligible if: - You are pregnant, breastfeeding, or planning pregnancy - You are contraindicated for the LUMINOR DEB per its instructions for use - You have a life expectancy of less than 1 year - You are currently in another investigational study - You have an acute vessel occlusion or visible blood clot in the target vessel Talk to your doctor to see if this trial is right for you.

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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