Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT03988166
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2019-06-13
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chronic Total Occlusion Percutaneous Coronary Intervention Study
Sponsor:
Vascular Solutions LLC
Organization:
Study Overview
Official Title:
Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTO-PCI
Brief 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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: