French multicentric registry on LUMINOR drug-eluting balloon for superficial femoral and popliteal arteries.
Caroline Caradu, Claire Webster, Bahaa Nasr...
https://pubmed.ncbi.nlm.nih.gov/39477043Actively Recruiting
Age: 18Years +
All Genders
ID04743180
European All-comers' Multicentric Prospective REGISTRY on LUMINOR Drug Eluting Balloon in the Superficial Femoral and Popliteal Arteries with 5 Years Follow-up
Led by iVascular S.L.U. · Updated on 2021-02-11
500
Participants Needed
15
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the safety, effectiveness, and cost-efficiency of the LUMINOR drug-eluting balloon in treating new and recurring blockages in the superficial femoral and popliteal arteries. This registry study includes all patients and pays special attention to those with calcified or long lesions, assessing the use of devices that remove blockages before applying the balloon. The study follows participants for five years to collect long-term data. Participants will be treated with the LUMINOR paclitaxel-eluting balloon device on their affected arteries. The study allows using additional tools such as laser or atherectomy devices during the initial procedure if needed to improve treatment outcomes. Some patients may require stenting after balloon treatment. The study observes patients over multiple years, monitoring various safety and effectiveness parameters. During the study, participants will undergo ultrasound imaging to check artery openness at 12 months and safety assessments up to 36 months. Researchers will track complications, revascularization procedures, amputations, and changes in symptoms and quality of life at several intervals up to five years. Cost-effectiveness will also be analyzed based on hospital and procedure expenses. Long-term follow-up visits will include questionnaires and clinical evaluations to monitor health status and treatment impact.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Rutherford Clinical Category 2 to 5
- Legally competent and voluntarily agrees to participate with signed informed consent
- Significant (70% or more) 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)
- Target lesion starting at the ostium of the superficial femoral artery and ending at the popliteal artery bifurcation, at least 1 cm above the tibial-peroneal trunk origin
- Patent inflow artery without significant (50% or more) stenosis
- Successful wire crossing and pre-dilatation of target lesion
- At least one patent native outflow artery to the ankle without significant (50% or more) stenosis
You will not qualify if you...
- Women who are pregnant, lactating, or planning pregnancy; men intending to father children
- Contraindication to use LUMINOR drug eluting balloon per current instructions
- Life expectancy less than 1 year
- Currently participating in another investigational drug or device study or previously enrolled in this study
- Inability to take required study medications or allergy to contrast that cannot be managed
- Sudden symptom onset, acute vessel occlusion, or acute/sub-acute thrombus in the target vessel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Implementation
Duration - Single procedure at enrollment
Participants receive treatment with the LUMINOR© paclitaxel eluting balloon in the superficial femoral and popliteal arteries.
1 procedure visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants are monitored for safety and efficacy outcomes over 5 years following the procedure.
Visits at 1, 6, 12, 24, 36, 48, and 60 months after the procedure
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
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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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