NCT03988166

Chronic Total Occlusion Percutaneous Coronary Intervention Study

Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Vascular Solutions LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.

Detailed description

A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study. The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll up to 150 patients to provide adequate powering for hypothesis testing and an evaluable sample size of at least 135 patients. The population for this study is participants with signs and/or symptoms considered typical of ischemic heart disease attributed to a de novo CTO in a native coronary artery who are suitable candidates for a percutaneous revascularization. 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). All study devices are currently 510(k) cleared for non-CTO indications. * GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo chronic total occlusions (CTO). * The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo chronic total occlusions (CTO). * The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires, to subselectively infuse/deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO). The Teleflex guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).

Conditions

• Chronic Total Occlusion
• Ischemic Heart Disease
• Chronic Total Occlusion of Coronary Artery

Interventions

Type	Name	Description
PROCEDURE	Chronic Total Occlusion Revascularization	Teleflex's series of study guidewires and catheters will be used to facilitate the safe and effective crossing of de novo CTOs and placement of conventional guidewires beyond the lesion via either a true lumen or subintimal pathway.
DEVICE	GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter	GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter

Timeline

• Start date: 2020-05-20
• Primary completion: 2021-02-22
• Completion: 2021-02-22
• First posted: 2019-06-17
• Last updated: 2022-09-28
• Results posted: 2022-09-28

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study