Registry on LUMINOR Drug Eluting Balloon for Treating Femoral and Popliteal Artery Conditions
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
This study is testing a new balloon treatment for people with serious blockages in their leg arteries to see how safe and effective it is over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iVascular S.L.U. Industry-sponsored |
| Locations | 15 sites (Bordeaux, New Aquitaine and 14 other locations) |
| Trial ID | NCT04743180 on ClinicalTrials.gov |
What this trial studies
This registry aims to evaluate the safety, efficacy, and cost-effectiveness of the LUMINOR© drug-eluting balloon in patients with significant stenosis or occlusion in the superficial femoral and popliteal arteries. It includes both de-novo and restenotic lesions, particularly focusing on challenging cases such as calcified or long lesions. The study will also assess the use of debulking devices to enhance drug penetration and treatment outcomes. Participants will be followed for five years to gather comprehensive data on the treatment's long-term effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant stenosis or occlusion in the femoropopliteal artery and classified under Rutherford Clinical Categories 2-5.
Not a fit: Patients with less than 70% stenosis or those with significant lesions in the inflow artery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with peripheral arterial disease, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with drug-eluting balloons in similar vascular conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years of age * Rutherford Clinical Category 2-5 * The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF) * Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery * TASC II Class A to D Lesions * de novo lesion(s), non-stented or stented restenotic lesion(s) * Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation * Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3) * A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication * Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use * At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure) Exclusion Criteria: * Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children * Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU) * Life expectancy of \< 1year * Patient is currently participating in an investigational drug or other device study or previously enrolled in this study * Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication * Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel
Where this trial is running
Bordeaux, New Aquitaine and 14 other locations
- Centre Hospitalier Universitaire Pellegrin — Bordeaux, New Aquitaine, France (Recruiting)
- Clinique Générale Annecy — Annecy, France (Recruiting)
- Clinique Rhône Durance — Avignon, France (Recruiting)
- Centre hospitalier de la Côte Basque — Bayonne, France (Recruiting)
- Polyclinic Bordeaux Nord Aquitaine — Bordeaux, France (Recruiting)
- Hôpital Ambroise Paré — Boulogne-Billancourt, France (Recruiting)
- Centre Hospitalier Régional Universitaire Morvan de Brest — Brest, France (Recruiting)
- CHRU Lille — Lille, France (Recruiting)
- Clinic Mutualiste Porte de L'Orient — Lorient, France (Recruiting)
- CHU Timone Marseille — Marseille, France (Recruiting)
- CH Layné — Mont-de-Marsan, France (Recruiting)
- Hôpital Privé des Franciscaines — Nîmes, France (Recruiting)
- Fondation Hôpital St Joseph — Paris, France (Recruiting)
- Clinique Saint Jean — Saint-Jean-de-Védas, France (Recruiting)
- Clinique Rhéna — Strasbourg, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.