June 2, 2020
Teleflex Commences Enrollment in CTO-PCI IDE Study
June 2, 2020—Teleflex Incorporated announced the first patient enrollment in a clinical study that will evaluate the performance of Teleflex coronary guidewires and specialty catheters in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures, which is currently an investigational indication for these products.
Study devices include the GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheter, and a series of five coronary guidewires (Spectre, R350, Raider, Warrior, and Bandit). These products are investigational devices for clinical evaluation as used in the CTO-PCI study. Each study device is currently commercially available in the United States under a more general indication, advised Teleflex.
The CTO-PCI Study is a prospective, single-arm investigational device exemption study enrolling up to 150 patients at approximately 15 investigational sites in the United States.
The primary angiographic endpoint is successful (intralumenal) guidewire placement beyond the CTO.
Additionally, the study will evaluate procedure success, the absence of major adverse cardiac events (MACE), the frequency of successful recanalization, 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).
Principal investigators of the study include David E. Kandzari, MD, and Dimitrios Karmpaliotis, MD. Dr. Kandzari is Director of CTO, Complex and High-Risk PCI at Columbia University Irving Medical Center in New York, New York. Dr. Karmpaliotis is Director, Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, Georgia.
“We’re excited to embark on the Teleflex CTO study,” commented Dr. Kandzari in the company's announcement. “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.”