Teleflex has announced the completion of patient enrolment in a clinical study evaluating the performance of Teleflex specialty catheters and coronary guidewires in Chronic Total Occlusion (CTO) percutaneous coronary intervention (PCI) procedures—currently an investigational indication for these products.
The study enrolled 150 patients across 13 investigational sites in the USA and completed enrolment three months ahead of schedule. The CTO-PCI study is a prospective, single-arm IDE study employing the primary angiographic endpoint of successful (intralumenal) guidewire placement beyond the CTO.
CTOs are longstanding complete blockages in coronary arteries that result in profound regional reduction of coronary blood flow (ischaemia). Clinically significant CTOs are found in nearly 20% of patients undergoing diagnostic coronary angiography for suspected ischemic heart disease. Often a source of limiting symptoms, CTOs may also contribute to cardiac dysfunction and are associated with poor prognosis.
The principal investigators of the study include David E Kandzari, director, Interventional Cardiology and chief of the Piedmont Heart Institute and Cardiovascular Service Line, Atlanta, USA, and Dimitri Karmpaliotis, director of CTO, Complex and High-Risk PCI at Columbia University Irving Medical Center, New York, USA. “The fast enrolment in the CTO-PCI study reflects the strong interest in further advancing contemporary techniques in CTO revascularisation—the most demanding PCI environment,” said Kandzari.
In addition to measuring procedure success and the absence of major adverse cardiac events (MACE), the study is evaluating 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 (defined as successful guidewire recanalization using Teleflex study devices).
Enrolling 30 of the 150 patients, Khaldoon Alaswad, director, Cardiac Catheterization Laboratory at Henry Ford Hospital, Detroit, USA, was the lead enroller in the study. “The study results will enhance the CTO-PCI skill set and inform interventionalists about the performance of the Teleflex product line in CTO procedures,” said Alaswad.
Study devices include the GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheter, and a series of five coronary guidewires (SpectreTM Guidewire, R350TM Guidewire, RaiderTM Guidewire, WarriorTM Guidewire and BanditTM Guidewire). Each study device is currently commercially available in the USA under a more general indication. These products are investigational devices for clinical evaluation as used in the CTO-PCI study.
“We are very encouraged by the brisk enrolment in the CTO-PCI IDE study and look forward to the results,” said Teleflex medical director, Christopher Buller.