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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02276313




Registration number
NCT02276313
Ethics application status
Date submitted
22/10/2014
Date registered
28/10/2014
Date last updated
31/05/2018

Titles & IDs
Public title
BIOLUX P-III All-Comers Passeo-18 Lux Registry
Scientific 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
Secondary ID [1] 0 0
C1211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 0 0
Peripheral Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Passeo-18 Lux

Treatment: Devices: Passeo-18 Lux
Endovascular Therapy

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Freedom from clinically-driven Target Lesion Revascularization (TLR)
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Freedom from clinically-driven TLR
Timepoint [1] 0 0
6 and 24 months
Secondary outcome [2] 0 0
Freedom from clinically-driven Target Vessel Revascularization (TVR)
Timepoint [2] 0 0
6 and 24 months
Secondary outcome [3] 0 0
Primary patency
Timepoint [3] 0 0
12 and 24 months
Secondary outcome [4] 0 0
Freedom from MAE
Timepoint [4] 0 0
12 and 24 months
Secondary outcome [5] 0 0
Change in mean Ankle Brachial Index
Timepoint [5] 0 0
6, 12 and 24 months
Secondary outcome [6] 0 0
Amputation-free survival
Timepoint [6] 0 0
6, 12 and 24 months
Secondary outcome [7] 0 0
Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire
Timepoint [7] 0 0
6, 12 and 24 months
Secondary outcome [8] 0 0
Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
Timepoint [8] 0 0
6, 12 and 24 months
Secondary outcome [9] 0 0
Device success - Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.
Timepoint [9] 0 0
Day 0
Secondary outcome [10] 0 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
Timepoint [10] 0 0
Day 0
Secondary outcome [11] 0 0
Procedural success - Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay
Timepoint [11] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cairns Hospital - Cairns
Recruitment hospital [2] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [3] 0 0
Geelong University Hospital - Geelong
Recruitment hospital [4] 0 0
Hollywood Hospital - Nedlands
Recruitment hospital [5] 0 0
The Townsville Hospital - Townsville
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Gateshead
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- Townsville
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Liege
Country [6] 0 0
Belgium
State/province [6] 0 0
Tienen
Country [7] 0 0
Denmark
State/province [7] 0 0
Kolding
Country [8] 0 0
Finland
State/province [8] 0 0
Tampere
Country [9] 0 0
France
State/province [9] 0 0
Clermont-Ferrand
Country [10] 0 0
France
State/province [10] 0 0
Essey Les Nancy
Country [11] 0 0
France
State/province [11] 0 0
Grenoble
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
Germany
State/province [13] 0 0
Arnsberg
Country [14] 0 0
Germany
State/province [14] 0 0
Bad Krozingen
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Giessen
Country [17] 0 0
Germany
State/province [17] 0 0
Göttingen
Country [18] 0 0
Germany
State/province [18] 0 0
Jena
Country [19] 0 0
Germany
State/province [19] 0 0
Kiel
Country [20] 0 0
Germany
State/province [20] 0 0
München Pasing
Country [21] 0 0
Germany
State/province [21] 0 0
Rosenheim
Country [22] 0 0
Italy
State/province [22] 0 0
Firenze
Country [23] 0 0
Italy
State/province [23] 0 0
San Donato Milanese
Country [24] 0 0
Latvia
State/province [24] 0 0
Riga
Country [25] 0 0
Malaysia
State/province [25] 0 0
Kuala Lumpur
Country [26] 0 0
Netherlands
State/province [26] 0 0
Eindhoven
Country [27] 0 0
Netherlands
State/province [27] 0 0
Tilburg
Country [28] 0 0
Portugal
State/province [28] 0 0
Almada
Country [29] 0 0
Singapore
State/province [29] 0 0
Singapore
Country [30] 0 0
Slovakia
State/province [30] 0 0
Kosice
Country [31] 0 0
Spain
State/province [31] 0 0
Badalona
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Leganés, Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Switzerland
State/province [35] 0 0
Lausanne
Country [36] 0 0
Switzerland
State/province [36] 0 0
Lugano
Country [37] 0 0
Switzerland
State/province [37] 0 0
Winterthur

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik AG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02276313
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gunnar Tepe, MD
Address 0 0
RoMed Klinikum Rosenheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02276313