Teleflex Incorporated, a US-based medical technologies provider, has enrolled the first patient in a clinical study that will evaluate performance of Teleflex coronary guidewires and specialty catheters.
The clinical trial is carried out to evaluate the products in Chronic Total Occlusion (CTO) percutaneous coronary intervention (PCI) procedures.
Teleflex medical director Chris Buller said: “The resourcing of this study by Teleflex reflects our commitment to providing the most advanced tools for our customers and their patients.
“The CTO-PCI study, led by Drs. Kandzari and Karmpaliotis, will evaluate the performance of the entire range of Teleflex complex PCI products in the most demanding PCI environment: chronic occlusive coronary disease.”
Teleflex will enrol up to 150 patients in CTO-PCI Study across 15 sites in the US
The CTO-PCI Study is a single-arm IDE study employing the primary angiographic endpoint of successful guidewire placement beyond the CTO, and will enrol up to 150 patients across 15 investigational sites in the US.
CTOs are longstanding complete blockages in coronary arteries that usually result in wide spread regional reduction of coronary blood flow (ischemia), and may also contribute to cardiac dysfunction and are associated with poor prognosis.
The study will deploy devices that include the GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheter, and a series of five coronary guidewires, including Spectre Guidewire, R350 Guidewire, Raider Guidewire, Warrior Guidewire and Bandit Guidewire.
The devices used in the CTO-PCI study are currently available in the US as investigational devices for clinical evaluation.
The study will measuring procedure success and the absence of major adverse cardiac events (MACE).
It is also expected to evaluate the frequency of successful recanalisation, frequency of MACE in-hospital and at 30 days post-procedure, frequency of clinically significant perforation, procedural success according to crossing technique, and technical success.
Principal investigator of the study David E Kandzari said: “We’re excited to embark on the Teleflex CTO study. We expect the study results to inform contemporary technique in CTO revascularization, a lesion complexity that has long been recognized as the most challenging in interventional cardiology.”
