BIOLUX P-I First in Man Study

Study Overview
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Brief Summary
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A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.

Official Title
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A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).

Conditions
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Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease

Intervention / Treatment
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* Device: Passeo-18 Lux DRB
* Device: Standard PTA (POBA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 years, Informed consent signed by patient prior to randomization Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long Rutherford Class 2 - 5 in the target limb Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation Inflow free from flow-limiting lesion (< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion has been treated successfully before the index procedure At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot Successful wire crossing of the lesion Willingness to comply with all specified follow-up evaluations Male or negative pregnancy test of women in childbearing age Exclusion Criteria: Co-morbid conditions limiting life expectancy ≤ 1 year Patient currently participating in another clinical trial Lesions which are untreatable with PTA or other interventional techniques The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion Thrombus in the target vessel, documented by angiography Target lesion is severely calcified, documented by angiography Prior bypass surgery of target vessel Previously implanted stent in the target lesion Treatment of bifurcation required Planned amputation of the target limb Flow-limiting (> 50% DS) Inflow lesion proximal to target lesion, left untreated Failure to obtain <30% residual stenosis in a pre-existing haemodynamically significant (>50% DS) inflow lesion in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion) Additional hemodynamically relevant proximal and distal lesions with stenosis ≥ 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis ≤ 30 % Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy Phenprocoumon intake Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment Known allergy to contrast media that cannot be adequately controlled with pre-medication Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Releasing Balloon<br>Passeo-18 Lux Drug Releasing Balloon catheter | Device: Passeo-18 Lux DRB<br> <br> * Other names: Passeo-18 Lux Drug Releasing Balloon catheter;|
| Active Comparator: Standard PT A (POBA)<br>Uncoated Passeo-18 PTA catheter | Device: Standard PTA (POBA)<br> <br> * Other names: Passeo-18 PTA catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months binary restenosis rate |  | 6 months | 
| 6 months and 12 months TLR rate |  | 6 and 12 months | 
| 6 months and 12 months change in mean ABI |  | 6 and 12 months | 
| 6 months and 12 months change in Rutherford class |  | 6 and 12 months | 
| Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR) |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenosis, Occlusions, SFA, PTA, POBA, DRB