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

NCT04743180 | Recruiting

• 1 other identifier: LUMIFOLLOW Registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 15

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.

Conditions

Angioplasty; Peripheral Arterial Disease; Drug-eluting Balloon; Femoral Artery; Paclitaxel

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images

  Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis.

  12 Months

• Overall Medical Safety

  Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 3 years from the following: index limb amputation (above or below the ankle), and all-cause mortality (with a detailed analysis of cardiovascular (CV) and non-CV deaths). Success is defined as freedom from all specified events; failure is defined as one or more specified events occurrences.

  36 Months

Secondary Outcomes (19)

• Secondary Endpoint Medical Safety: Major vascular complications

  ≤30 days after index procedure

• Secondary Endpoint Medical Safety: Composite Safety

  1, 6, 12, 36, 48, 60 months after index procedure

• Secondary Endpoint Medical Safety: All-cause death

  1, 6, 12, 24, 36, 48, 60 months after index procedure

• Secondary Endpoint Medical Safety: Major amputation at target limb

  1, 6, 12, 24, 36, 48, 60 months after index procedure

• Secondary Endpoint Medical Safety: Minor amputation at target limb

  1, 6, 12, 24, 36, 48, 60 months after index procedure

Study Arms (1)

LUMINOR© drug eluting balloon

Device: LUMINOR© Paclitaxel eluting balloon

Interventions

LUMINOR© Paclitaxel eluting balloon DEVICE

Patients will be treated with the Luminor paclitaxel eluting balloon

LUMINOR© drug eluting balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (15)

Centre Hospitalier Universitaire Pellegrin

Bordeaux, Nouvelle-Aquitaine, 33000, France

RECRUITING

Clinique Générale Annecy

Annecy, 74000, France

RECRUITING

Clinique Rhône Durance

Avignon, 84000, France

RECRUITING

Centre hospitalier de la Côte Basque

Bayonne, 64100, France

RECRUITING

Polyclinic Bordeaux Nord Aquitaine

Bordeaux, 33300, France

RECRUITING

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

RECRUITING

Centre Hospitalier Régional Universitaire Morvan de Brest

Brest, 29200, France

RECRUITING

CHRU Lille

Lille, 59000, France

RECRUITING

Clinic Mutualiste Porte de L'Orient

Lorient, 56100, France

RECRUITING

CHU Timone Marseille

Marseille, 13005, France

RECRUITING

CH Layné

Mont-de-Marsan, 40024, France

RECRUITING

Hôpital Privé des Franciscaines

Nîmes, 30000, France

RECRUITING

Fondation Hôpital St Joseph

Paris, 75014, France

RECRUITING

Clinique Saint Jean

Saint-Jean-de-Védas, 34430, France

RECRUITING

Clinique Rhéna

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 8, 2021
• Study Start: January 18, 2021
• Primary Completion: June 1, 2022
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)