Teleflex Completes Enrollment in CTO-PCI IDE Study

February 17, 2021—Teleflex Incorporated announced the completion of patient enrollment in a clinical study evaluating the performance of Teleflex specialty catheters and coronary guidewires in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures, which is currently an investigational indication for these products.

According to Teleflex, the CTO-PCI study is a prospective, single-arm, investigational device exemption (IDE) study employing the primary angiographic endpoint of successful (intralumenal) guidewire placement beyond the CTO.

In addition to measuring procedural success and the absence of major adverse cardiac events (MACE), the study is evaluating the frequency of successful recanalization, frequency of in-hospital MACE and at 30 days postprocedure, frequency of clinically significant perforation, procedural success according to crossing technique, and technical success (defined as successful guidewire recanalization using Teleflex study devices).

Teleflex study devices include the GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheter, and a series of five coronary guidewires (Spectre, R350, Raider, Warrior, and Bandit). Each study device is currently commercially available in the United States under a more general indication. These products are investigational devices for clinical evaluation as used in the CTO-PCI IDE study, advised Teleflex.

The study enrolled 150 patients at 13 investigational sites in the United States. Enrollment was completed 3 months ahead of schedule, noted the company.

Khaldoon Alaswad, MD, Director of the Cardiac Catheterization Laboratory at Henry Ford Hospital in Detroit, Michigan, enrolled 30 of the 150 patients and 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,” stated Dr. Alaswad in the Teleflex press release.

The Principal Investigators of the study include David E. Kandzari, MD, and Dimitri Karmpaliotis, MD.

Dr. Kandzari is Director of Interventional Cardiology and Chief of the Piedmont Heart Institute and Cardiovascular Service Line in Atlanta, Georgia. Dr. Karmpaliotis is Director of CTO, Complex, and High-Risk PCI at Columbia University Irving Medical Center in New York, New York.

“The fast enrollment in the CTO-PCI study reflects the strong interest in further advancing contemporary techniques in CTO revascularization—the most demanding PCI environment,” stated Dr. Kandzari in the company’s announcement.