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Trial registered on ANZCTR
Registration number
ACTRN12624000999538p
Ethics application status
Submitted, not yet approved
Date submitted
11/07/2024
Date registered
16/08/2024
Date last updated
16/08/2024
Date data sharing statement initially provided
16/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Study of a New Microcatheter, the Corsair Pro SC, for Treatment of Blocked Arteries in the Heart
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Scientific title
Evaluation of the Performance of a New Microcatheter, the Corsair Pro SC, in Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusions (CTO)
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Secondary ID [1]
312505
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None
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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:
Coronary artery disease
334370
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Condition category
Condition code
Cardiovascular
331011
331011
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0
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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
This study will evaluate the performance of a new microcatheter Corsair Pro SC in percutaneous coronary intervention (PCI) for chronic total occlusions CTO. The Corsair Pro SC represents an evolution of the Asahi Corsair Pro microcatheter which is used commercially and approved internationally for use in CTO PCI. The main difference between the Corsair Pro and the Corsair Pro SC is the addition of a screw-like structure to the distal shaft. The changes made to the Corsair Pro SC are intended to facilitate the entry of the microcatheter into the CTO and create an anchor effect once the microcatheter is advanced into the CTO with the aim of improving wire manoeuvrability (torque and push) and crossability. During the CTO PCI the Corsair Pro SC will be advanced through a coronary guide catheter, over a wire, into the artery. The Corsair Pro SC will be used in combination with a coronary CTO wire to facilitate crossing of the CTO. Once the CTO has been successfully crossed the Corsair Pro SC microcatheter will be removed. Dilation of the lesion with a balloon and placement of coronary stent will then be performed. In this study the Corsair Pro SC microcatheter will be used during PCI in patients with CTO of their coronary arteries instead of a commercially available microcatheter. Performance of the microcatheter with be observed directly and recorded on coronary angiography using X-rays. The investigational procedures will be performed in the cardiac catheterisation laboratory of Wellington Regional Hospital by experienced Interventional Cardiologists
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Intervention code [1]
329023
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Treatment: Devices
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Successful crossing of the CTO with a coronary guide wire
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Assessment method [1]
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Assessed by coronary angiography using x-ray images
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Timepoint [1]
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Outcome will be assess upon completion of the PCI
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Secondary outcome [1]
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MACE (composite of cardiovascular death, myocardial infarction, or target vessel revascularisation)
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Assessment method [1]
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Clinical follow-up through review of medical records and telephone follow-up.
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Timepoint [1]
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30 days post PCI
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Secondary outcome [2]
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Technical success (Thrombolysis in Myocardial Infarction (TIMI) grade 2 or greater flow with <30% residual stenosis of the target CTO lesion).
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Assessment method [2]
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Angiographic review using X-ray images)
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Timepoint [2]
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Upon completion of the index PCI
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Secondary outcome [3]
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Procedural success (technical success without MACE)
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Assessment method [3]
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Angiographic review using X-ray, clinical review of the patient and review of medical records
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Timepoint [3]
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At hospital discharge, at 7 days post PCI or death, which ever occurs first.
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Eligibility
Key inclusion criteria
For inclusion in the study participants are required fulfil the following criteria:
1. 18 years or older
2. Patients undergoing PCI for CTO.
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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
Participants should not enter the study if any of the following exclusion criteria are fulfilled:
• Those presenting for primary PCI with ST-segment-elevation Myocardial Infarction (STEMI)
• Dual antithrombotic therapy is contraindicated
• Inability to give informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2024
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Actual
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Date of last participant enrolment
Anticipated
30/12/2024
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Actual
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Date of last data collection
Anticipated
31/01/2025
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Actual
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Sample size
Target
9
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Wellington
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Bio-Excel (NZ) Limited
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Professor Scott Harding
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319171
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Country [1]
319171
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315680
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Southern Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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31/07/2024
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Approval date [1]
315680
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Ethics approval number [1]
315680
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Summary
Brief summary
Chronic total occlusions (CTOs) or complete blockages of the coronary arteries are relatively common and represent the most difficult lesion subset to achieve coronary guide wire crossing and successful PCI (reopening of the blockage). Routine use of microcatheters in conjunction with a guide wire is recommended for CTO PCI. A new microcatheter, the Corsair Pro SC, has been developed which incorporates a screw-like structure in the distal shaft to facilitate the entry of the microcatheter into the coronary blockage. We hypothesize that this new microcatheter design will improve back-up support, manoeuvrability (torque and push) resulting in greater success in crossing and opening complete blockages in the coronary arteries. The aim of this first in human study is to assess the performance of the Corsair Pro SC microcatheter in PCI for chronic total occlusions (CTO).
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Trial website
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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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Prof Scott Harding
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Address
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Cardiology Department, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country
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New Zealand
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Phone
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+64 274456171
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Fax
135486
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Email
135486
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[email protected]
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Contact person for public queries
Name
135487
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Scott Harding
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Address
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Cardiology Department, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country
135487
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New Zealand
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Phone
135487
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+64 274456171
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Fax
135487
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Email
135487
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[email protected]
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Contact person for scientific queries
Name
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Scott Harding
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Address
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Cardiology Department, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
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Country
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New Zealand
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Phone
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+64 274456171
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Fax
135488
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Email
135488
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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