None listed
Conditions
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).
Interventions
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
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
Sponsors
Professor Scott Harding
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed