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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/NCT01939249
Registration number
NCT01939249
Ethics application status
Date submitted
6/09/2013
Date registered
11/09/2013
Date last updated
26/06/2017
Titles & IDs
Public title
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
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Scientific title
BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV
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Secondary ID [1]
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C1204
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Universal Trial Number (UTN)
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Trial acronym
BIOFLOW-IV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Abbott Laboratories Xience
Treatment: Devices - Biotronik Orsiro
Active Comparator: Abbott Laboratories Xience - Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
Experimental: Biotronik Orsiro - Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Treatment: Devices: Abbott Laboratories Xience
Treatment: Devices: Biotronik Orsiro
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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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Target Vessel Failure
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Assessment method [1]
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Timepoint [1]
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12 months post index procedure
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Secondary outcome [1]
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Rate of clinically-driven target lesion revascularization (TLR)
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Assessment method [1]
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Timepoint [1]
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1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
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Secondary outcome [2]
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Rate of clinically-driven target vessel revascularization (TVR)
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Assessment method [2]
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Timepoint [2]
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1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
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Secondary outcome [3]
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Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR
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Assessment method [3]
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Timepoint [3]
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1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
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Eligibility
Key inclusion criteria
Main
- Subject must provide written informed consent
- The target reference vessel diameter (RVD) is = 2.50 mm and = 3.75 mm assessed either
visually or by online QCA.
- Target lesion length is = 26 mm (assessed either visual estimate or by online QCA) and
can be covered by one study stent
- Single de novo lesion with = 50% and < 100% stenosis in up to 2 coronary arteries
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Minimum age
18
Years
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Maximum age
80
Years
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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
- Subject has evidence of myocardial infarction within 72 hours prior to the index
procedure
- Planned intervention of non-target vessel(s) within 30 days after the index procedure
- Planned intervention of target vessel(s) after the index procedure
- Target lesion is located in the left main
- Target lesion is located in or supplied by an arterial or venous bypass graft
- Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by
online QCA
- Proximal or distal to the target lesion located stenosis that might require future
revascularization or impede run off
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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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
1/09/2013
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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
1/01/2020
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Actual
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Sample size
Target
585
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [2]
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Prince of Wales Hospital Sydney - Sydney
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Recruitment postcode(s) [1]
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6961 - Murdoch
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Recruitment postcode(s) [2]
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NSW 2031 - Sydney
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Recruitment outside Australia
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Belgium
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Leuven,
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Belgium
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Roeselare
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Denmark
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Roskilde
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Germany
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Bad Krozingen
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Germany
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Bad Oeynhausen
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Germany
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Bad Segeberg
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dachau
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Germany
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Hannover
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Germany
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Nürnberg
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Israel
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Haifa
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Israel
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Jerusalem,
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Israel
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Petach Tikva
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Kumamoto
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Tokyo
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Amsterdam
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Blaricum
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Zwolle
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Christchurch
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Poland
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Krakow
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Poland
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Lubin
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Poznan
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Warsaw
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Barcelona
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Santander
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Oerebrö
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Uppsala
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Lausanne
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Switzerland
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Lugano
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Switzerland
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Zürich
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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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Ethics approval
Ethics application status
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Summary
Brief summary
BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The
purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the
Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary
lesions. The study is powered for non-inferiority with respect to Target Vessel
Failure(TVF)at 12 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01939249
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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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Shigeru Saito, MD
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Address
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Okinawa Tokushukai Shonan Kamakura General Hospital
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01939249
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