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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
Scientific title
Evaluation of the Performance of a New Microcatheter, the Corsair Pro SC, in Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusions (CTO)
Secondary ID [1] 312505 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 334370 0
Condition category
Condition code
Cardiovascular 331011 331011 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 329023 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338774 0
Successful crossing of the CTO with a coronary guide wire
Timepoint [1] 338774 0
Outcome will be assess upon completion of the PCI
Secondary outcome [1] 437397 0
MACE (composite of cardiovascular death, myocardial infarction, or target vessel revascularisation)
Timepoint [1] 437397 0
30 days post PCI
Secondary outcome [2] 437398 0
Technical success (Thrombolysis in Myocardial Infarction (TIMI) grade 2 or greater flow with <30% residual stenosis of the target CTO lesion).
Timepoint [2] 437398 0
Upon completion of the index PCI
Secondary outcome [3] 437400 0
Procedural success (technical success without MACE)
Timepoint [3] 437400 0
At hospital discharge, at 7 days post PCI or death, which ever occurs first.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment outside Australia
Country [1] 26417 0
New Zealand
State/province [1] 26417 0
Wellington

Funding & Sponsors
Funding source category [1] 316930 0
Commercial sector/Industry
Name [1] 316930 0
Bio-Excel (NZ) Limited
Country [1] 316930 0
New Zealand
Primary sponsor type
Individual
Name
Professor Scott Harding
Address
Country
New Zealand
Secondary sponsor category [1] 319171 0
None
Name [1] 319171 0
Address [1] 319171 0
Country [1] 319171 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315680 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315680 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 315680 0
New Zealand
Date submitted for ethics approval [1] 315680 0
31/07/2024
Approval date [1] 315680 0
Ethics approval number [1] 315680 0

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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135486 0
Prof Scott Harding
Address 135486 0
Cardiology Department, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 135486 0
New Zealand
Phone 135486 0
+64 274456171
Fax 135486 0
Email 135486 0
[email protected]
Contact person for public queries
Name 135487 0
Scott Harding
Address 135487 0
Cardiology Department, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 135487 0
New Zealand
Phone 135487 0
+64 274456171
Fax 135487 0
Email 135487 0
[email protected]
Contact person for scientific queries
Name 135488 0
Scott Harding
Address 135488 0
Cardiology Department, Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 135488 0
New Zealand
Phone 135488 0
+64 274456171
Fax 135488 0
Email 135488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.