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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276313
• Other study ID #: C1211
• Status: Completed
• Start date: October 2014
• Est. completion date: January 2022

Study information

• Verified date: August 2022
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: January 2022
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Passeo-18 Lux
Endovascular Therapy

Locations

Country	Name	City	State
Australia	Cairns Hospital	Cairns
Australia	Lake Macquarie Private Hospital	Gateshead
Australia	Geelong University Hospital	Geelong
Australia	Hollywood Hospital	Nedlands
Australia	The Townsville Hospital	Townsville
Austria	Medizinische Universität Graz	Graz
Austria	Department Radiologie, Universitätsklinik für Radiodiagnostik	Innsbruck
Belgium	UCL St. Luc	Brussels
Belgium	UZ Leuven	Leuven
Belgium	CHR de la Citadelle	Liege
Belgium	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen
Denmark	Kolding Hospital	Kolding
Finland	Tampereen Yliopiostollinen Keskussariaaia	Tampere
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	Clinique Pasteur Essey Les Nancy	Essey Les Nancy
France	CHU de Grenoble	Grenoble
France	Hospices Civils de Lyon	Lyon
Germany	Klinikum Arnsberg, Karolinenhospital	Arnsberg
Germany	Department of Angiology at Universitats- Herzzentrum Freiburg	Bad Krozingen
Germany	Gemeinschaftspraxis für Radiologie	Berlin
Germany	Sank Gertrauden-Krankenhaus	Berlin
Germany	Universitätsklinikum Giessen und Marburg GmbH	Giessen
Germany	Herz- und Gefässzentrum Göttingen	Göttingen
Germany	Universitätsklinikum Jena	Jena
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Kliniken München Pasing-Perlach GmbH	München Pasing
Germany	RoMed Klinikum Rosenheim	Rosenheim
Italy	Ospedale San Giovanni di Dio	Firenze
Italy	Policlinico San Donato	San Donato Milanese
Latvia	P.Stradins Clinical University Hospital, Institute of Diagnostic	Riga
Malaysia	Institute Jantung Negara	Kuala Lumpur
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Saint Elisabeth Hospital	Tilburg
Portugal	Hospital Garcia de Orta	Almada
Singapore	Changi General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Slovakia	Institute of Cardiovascular diseases Kosice, Dpt. of Angiology	Kosice
Spain	Hospital. Universitario Germans Trias i Pujol	Badalona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Severo Ochoa	Madrid
Switzerland	Centre Hopsitalier Universitaire Vaudois	Lausanne
Switzerland	Ospedale Regionale di Lugano	Lugano
Switzerland	KS Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Italy,  Latvia,  Malaysia,  Netherlands,  Portugal,  Singapore,  Slovakia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from clinically-driven Target Lesion Revascularization (TLR)		12 months
Secondary	Freedom from clinically-driven TLR		6 and 24 months
Secondary	Freedom from clinically-driven Target Vessel Revascularization (TVR)		6 and 24 months
Secondary	Primary patency		12 and 24 months
Secondary	Freedom from MAE		12 and 24 months
Secondary	Change in mean Ankle Brachial Index		6, 12 and 24 months
Secondary	Amputation-free survival		6, 12 and 24 months
Secondary	Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire		6, 12 and 24 months
Secondary	Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification		6, 12 and 24 months
Secondary	Device success	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.	Day 0
Secondary	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
Secondary	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