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

Biotronik AG880 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

880

Conditions

Atherosclerosis Peripheral Artery Disease

Interventions

Passeo-18 LuxDEVICE

Endovascular Therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (45)

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Freedom from clinically-driven Target Lesion Revascularization (TLR)

Time frame: 12 months

Secondary Outcomes

Freedom from clinically-driven TLR

Time frame: 6 and 24 months

Freedom from clinically-driven Target Vessel Revascularization (TVR)

Time frame: 6 and 24 months

Primary patency

Time frame: 12 and 24 months

Freedom from MAE

Time frame: 12 and 24 months

Change in mean Ankle Brachial Index

Time frame: 6, 12 and 24 months

Amputation-free survival

Time frame: 6, 12 and 24 months

Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire

Time frame: 6, 12 and 24 months

Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification

Time frame: 6, 12 and 24 months

Data from ClinicalTrials.gov

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Medizinische Universität Graz

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Leuven, Belgium

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Liège, Belgium

...and 35 more locations