BIOLUX P-III All-Comers Passeo-18 Lux Registry

Study Overview
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Brief Summary
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BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

Detailed Description
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The Passeo-18 LUX Paclitaxel Releasing BalloonCatheter is a novel drug-releasing balloon that received CE-mark in January 2014. Its safety and efficacy has been investigated in two randomized First-in-Man trials in patients with stenosis or occlusion of the femoropopliteal (BIOLUX P-I) and infrapopliteal (BIOLUX P-II) arteries when compared to an uncoated device. The purpose of the BIOLUX P-III all-comers registry is to collect short and long-term clinical performance data on the Passeo-18 Lux DRB in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in daily clinical practice.

Official Title
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BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III

Conditions
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Atherosclerosis, Peripheral Artery Disease

Intervention / Treatment
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* Device: Passeo-18 Lux


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years or minimum age as required by local regulations Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable Lesion(s) in the infrainguinal arteries suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon Exclusion Criteria: Life expectancy ≤ 1 year Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet Subject is pregnant or planning to become pregnant during the course of the study Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Passeo-18 Lux|Endovascular Therapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Major Adverse Events (MAE) | A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) within 6 months post-index procedure. | 6 months | 
| Freedom from clinically-driven Target Lesion Revascularization (TLR) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from clinically-driven TLR |  | 6 and 24 months | 
| Freedom from clinically-driven Target Vessel Revascularization (TVR) |  | 6 and 24 months | 
| Primary patency |  | 12 and 24 months | 
| Freedom from MAE |  | 12 and 24 months | 
| Change in mean Ankle Brachial Index |  | 6, 12 and 24 months | 
| Amputation-free survival |  | 6, 12 and 24 months | 
| Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire |  | 6, 12 and 24 months | 
| Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification |  | 6, 12 and 24 months | 
| Device success | Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB. | Day 0 | 
| Technical success | Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation | Day 0 | 
| Procedural success | Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral, Infrainguinal, Drug Releasing Balloon, Drug Eluting Balloon