Status:
RECRUITING
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
Lead Sponsor:
iVascular S.L.U.
Conditions:
Angioplasty
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Brief 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, especial...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04743180
Start Date
January 18 2021
End Date
June 30 2026
Last Update
February 11 2021
Active Locations (15)
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1
Centre Hospitalier Universitaire Pellegrin
Bordeaux, Nouvelle-Aquitaine, France, 33000
2
Clinique Générale Annecy
Annecy, France, 74000
3
Clinique Rhône Durance
Avignon, France, 84000
4
Centre hospitalier de la Côte Basque
Bayonne, France, 64100