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

Completed

• Conditions: Atherosclerosis; Peripheral Artery Disease

• Registration Number: NCT02276313
• Lead Sponsor: Biotronik AG

Brief Summary

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

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-28
• Primary Completion: 2018-04
• Study Completion: 2022-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 880

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from Major Adverse Events (MAE)	6 months	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.
Freedom from clinically-driven Target Lesion Revascularization (TLR)	12 months

Secondary Outcome Measures

Name	Time	Method
Freedom from clinically-driven TLR	6 and 24 months
Freedom from MAE	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
Technical success	Day 0	Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation
Freedom from clinically-driven Target Vessel Revascularization (TVR)	6 and 24 months
Primary patency	12 and 24 months
Amputation-free survival	6, 12 and 24 months
Device success	Day 0	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.
Procedural success	Participants will be followed for the duration of hospital stay, an expected average of 1-2 days	Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay
Change in mean Ankle Brachial Index	6, 12 and 24 months

Trial Locations

Locations (45)

Cairns Hospital; 🇦🇺 Cairns, Australia

Lake Macquarie Private Hospital; 🇦🇺 Gateshead, Australia

Geelong University Hospital; 🇦🇺 Geelong, Australia

Hollywood Hospital; 🇦🇺 Nedlands, Australia

The Townsville Hospital; 🇦🇺 Townsville, Australia

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Department Radiologie, Universitätsklinik für Radiodiagnostik; 🇦🇹 Innsbruck, Austria

UCL St. Luc; 🇧🇪 Brussels, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

CHR de la Citadelle; 🇧🇪 Liege, Belgium

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