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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02276313
Registration number
NCT02276313
Ethics application status
Date submitted
22/10/2014
Date registered
28/10/2014
Date last updated
15/08/2022
Titles & IDs
Public title
BIOLUX P-III All-Comers Passeo-18 Lux Registry
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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
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Secondary ID [1]
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C1211
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis
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Peripheral Artery Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Passeo-18 Lux
Treatment: Devices: Passeo-18 Lux
Endovascular Therapy
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Freedom from Major Adverse Events (MAE)
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Assessment method [1]
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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.
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Timepoint [1]
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6 months
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Primary outcome [2]
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Freedom from clinically-driven Target Lesion Revascularization (TLR)
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Assessment method [2]
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Timepoint [2]
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12 months
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Secondary outcome [1]
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Freedom from clinically-driven TLR
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Assessment method [1]
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Timepoint [1]
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6 and 24 months
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Secondary outcome [2]
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Freedom from clinically-driven Target Vessel Revascularization (TVR)
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Assessment method [2]
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Timepoint [2]
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6 and 24 months
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Secondary outcome [3]
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Primary patency
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Assessment method [3]
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Timepoint [3]
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12 and 24 months
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Secondary outcome [4]
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Freedom from MAE
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Assessment method [4]
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Timepoint [4]
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12 and 24 months
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Secondary outcome [5]
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Change in mean Ankle Brachial Index
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Assessment method [5]
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Timepoint [5]
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6, 12 and 24 months
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Secondary outcome [6]
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Amputation-free survival
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Assessment method [6]
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Timepoint [6]
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6, 12 and 24 months
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Secondary outcome [7]
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Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire
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Assessment method [7]
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Timepoint [7]
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6, 12 and 24 months
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Secondary outcome [8]
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Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
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Assessment method [8]
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Timepoint [8]
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6, 12 and 24 months
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Secondary outcome [9]
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Device success
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Assessment method [9]
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Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.
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Timepoint [9]
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Day 0
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Secondary outcome [10]
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Technical success
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Assessment method [10]
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Successful completion of the endovascular procedure and immediate morphological success with = 50% residual diameter reduction of the treated lesion as determined by visual estimation
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Timepoint [10]
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Day 0
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Secondary outcome [11]
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Procedural success
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Assessment method [11]
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Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay
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Timepoint [11]
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Participants will be followed for the duration of hospital stay, an expected average of 1-2 days
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2022
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Sample size
Target
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Accrual to date
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Final
880
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cairns Hospital - Cairns
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Recruitment hospital [2]
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Lake Macquarie Private Hospital - Gateshead
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Recruitment hospital [3]
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Geelong University Hospital - Geelong
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Recruitment hospital [4]
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Hollywood Hospital - Nedlands
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Recruitment hospital [5]
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The Townsville Hospital - Townsville
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Recruitment postcode(s) [1]
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- Cairns
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Recruitment postcode(s) [2]
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- Gateshead
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Recruitment postcode(s) [3]
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- Geelong
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Recruitment postcode(s) [4]
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- Nedlands
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Recruitment postcode(s) [5]
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- Townsville
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Graz
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Country [2]
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Austria
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Innsbruck
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Belgium
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Brussels
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Belgium
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Leuven
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Belgium
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Liege
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Country [6]
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Belgium
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State/province [6]
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Tienen
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Country [7]
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Denmark
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State/province [7]
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Kolding
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Finland
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State/province [8]
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Tampere
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France
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State/province [9]
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Clermont-Ferrand
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France
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State/province [10]
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Essey Les Nancy
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Country [11]
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France
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State/province [11]
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Grenoble
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Country [12]
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France
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State/province [12]
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Lyon
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Country [13]
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Germany
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State/province [13]
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Arnsberg
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Germany
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State/province [14]
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Bad Krozingen
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Country [15]
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Germany
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State/province [15]
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Berlin
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Country [16]
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Germany
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State/province [16]
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Giessen
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Germany
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Göttingen
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Germany
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Jena
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Country [19]
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Germany
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State/province [19]
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Kiel
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Country [20]
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Germany
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State/province [20]
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München Pasing
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Country [21]
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Germany
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State/province [21]
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Rosenheim
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Italy
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Firenze
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Country [23]
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Italy
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San Donato Milanese
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Latvia
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Riga
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Malaysia
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Kuala Lumpur
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Netherlands
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Eindhoven
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Netherlands
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Tilburg
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Portugal
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Almada
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Singapore
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Singapore
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Slovakia
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State/province [30]
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Kosice
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Spain
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Badalona
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Country [32]
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Lausanne
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Switzerland
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Lugano
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Country [36]
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Switzerland
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State/province [36]
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Winterthur
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik AG
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02276313
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gunnar Tepe, MD
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Address
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RoMed Klinikum Rosenheim
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02276313
Download to PDF