Clinical trial NCT04743180: European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angioplasty
Peripheral Arterial Disease
Drug-eluting Balloon
Femoral Artery
Paclitaxel
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral artery disease due to occlusive lesions, stenosis of ingraguinal arteries and restenosis after previous angioplasty with/without stent in that sector.

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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images
timeFrame: 12 Months
measure: Overall Medical Safety
timeFrame: 36 Months
Secondary outcomes:
measure: Secondary Endpoint Medical Safety: Major vascular complications
timeFrame: ≤30 days after index procedure
measure: Secondary Endpoint Medical Safety: Composite Safety
timeFrame: 1, 6, 12, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Medical Safety: All-cause death
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Medical Safety: Major amputation at target limb
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Medical Safety: Minor amputation at target limb
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Medical Safety: Target Limb Reintervention
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Acute Device Success
timeFrame: During index procedure
measure: Secondary Endpoint Efficacy: Technical Success
timeFrame: During index procedure
measure: Secondary Endpoint Efficacy: Procedural Success
timeFrame: Up to 30 days
measure: Secondary Endpoint Efficacy: Primary Patency
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Secondary Patency
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Change of Rutherford classification from baseline
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
measure: Secondary Endpoint Cost-Effectiveness (optional): factoring procedure and hospital admission costs
timeFrame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire Pellegrin
state: Nouvelle-Aquitaine
city: Annecy
country: France
facility: Clinique Générale Annecy
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Bayonne
country: France
facility: Centre hospitalier de la Côte Basque
city: Bordeaux
country: France
facility: Polyclinic Bordeaux Nord Aquitaine
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire Morvan de Brest
city: Lille
country: France
facility: CHRU Lille
city: Lorient
country: France
facility: Clinic Mutualiste Porte de L'Orient
city: Marseille
country: France
facility: CHU Timone Marseille
city: Mont-de-Marsan
country: France
facility: CH Layné
city: Nîmes
country: France
facility: Hôpital Privé des Franciscaines
city: Paris
country: France
facility: Fondation Hôpital St Joseph
city: Saint-Jean-de-Védas
country: France
facility: Clinique Saint Jean
city: Strasbourg
country: France
facility: Clinique Rhéna
Study officials:
References: