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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Angioplasty Peripheral Arterial Disease Drug-eluting Balloon Femoral Artery Paclitaxel

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LUMINOR© drug eluting balloon

LUMINOR© Paclitaxel eluting balloon

Intervention Type DEVICE

Patients will be treated with the Luminor paclitaxel eluting balloon

Interventions

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LUMINOR© Paclitaxel eluting balloon

Patients will be treated with the Luminor paclitaxel eluting balloon

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No