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

iVascular

Status: Enrolling

Conditions: Drug-eluting Balloon; Paclitaxel; Angioplasty; Femoral Artery; Peripheral Arterial Disease

Treatments: Device: LUMINOR© Paclitaxel eluting balloon

Study type: Observational

Funder types: Industry

Identifiers

NCT04743180

LUMIFOLLOW Registry

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

LUMINOR© drug eluting balloon

Treatment:

Device: LUMINOR© Paclitaxel eluting balloon