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

Launched by IVASCULAR S.L.U. · Feb 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a special type of balloon called the LUMINOR© Drug Eluting Balloon (DEB) for treating blocked arteries in the legs, specifically the femoral and popliteal arteries. The goal is to see how well this treatment works for patients with new blockages as well as those who have had previous treatments that didn't fully work. The trial will also look at whether using additional tools to prepare the artery helps the medication from the balloon reach the affected area better, especially in more complicated cases.

To be eligible to participate, you need to be at least 18 years old and have significant blockage in your leg arteries. This includes patients with varying levels of symptoms related to poor blood flow. Participants will need to be able to commit to the study for five years, which involves regular check-ups and follow-ups after the treatment. It’s important to note that certain people, like pregnant women or those with serious health issues, may not be able to join. If you qualify and decide to participate, you can expect careful monitoring and support throughout the process to ensure your safety.

Gender

ALL

Eligibility 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