Actively 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.
Led by iVascular S.L.U. · Updated on 2021-02-11
500
Participants Needed
15
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Rutherford Clinical Category 2 to 5
- Legally competent and willing to provide informed consent for 5 years
- Significant 70% or greater stenosis or occlusion of native femoropopliteal artery
- TASC II Class A to D lesions
- De novo or non-stented/stented restenotic lesions
- Target lesion starts at ostium of superficial femoral artery just below common femoral bifurcation
- Target lesion ends at popliteal artery bifurcation and at least 1 cm above origin of TP trunk (P3)
- Patent inflow artery free from significant 50% or greater stenosis
- Successful wire crossing and pre-dilatation of target lesion
- At least one patent native outflow artery to the ankle free from significant 50% or greater stenosis
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy, or men planning to father children
- Contraindication to use Luminor Drug Eluting Balloon per Instructions For Use
- Life expectancy less than 1 year
- Currently or previously participating in investigational drug or device study
- Inability to take required study medications or allergy to contrast not manageable by medication
- Sudden symptom onset, acute vessel occlusion, or visible acute/sub-acute thrombus in target vessel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Centre Hospitalier Universitaire Pellegrin
Bordeaux, New Aquitaine, France, 33000
Actively Recruiting
2
Clinique Générale Annecy
Annecy, France, 74000
Actively Recruiting
3
Clinique Rhône Durance
Avignon, France, 84000
Actively Recruiting
4
Centre hospitalier de la Côte Basque
Bayonne, France, 64100
Actively Recruiting
5
Polyclinic Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Actively Recruiting
6
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92100
Actively Recruiting
7
Centre Hospitalier Régional Universitaire Morvan de Brest
Brest, France, 29200
Actively Recruiting
8
CHRU Lille
Lille, France, 59000
Actively Recruiting
9
Clinic Mutualiste Porte de L'Orient
Lorient, France, 56100
Actively Recruiting
10
CHU Timone Marseille
Marseille, France, 13005
Actively Recruiting
11
CH Layné
Mont-de-Marsan, France, 40024
Actively Recruiting
12
Hôpital Privé des Franciscaines
Nîmes, France, 30000
Actively Recruiting
13
Fondation Hôpital St Joseph
Paris, France, 75014
Actively Recruiting
14
Clinique Saint Jean
Saint-Jean-de-Védas, France, 34430
Actively Recruiting
15
Clinique Rhéna
Strasbourg, France, 67000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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