Chronic Total Occlusion, Chronic Total Occlusion of Coronary Artery, Ischemic Heart Disease
Conditions
Keywords
Chronic Total Occlusion, Percutaneous revascularization
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).
Interventions
PROCEDUREChronic 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.
DEVICEGuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
Sponsors
Teleflex
Bright Research Partners
Vascular Solutions LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following inclusion criteria: General inclusion criteria 1. At least 18 years of age at the time of consent 2. Experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization 3. Participant is eligible and consents to undergo PCI procedure 4. Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG) 5. Willing and able to sign a study Informed Consent Form (ICF) approved by a local or central Institutional Review Board (IRB) 6. Female participants of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception Angiographic inclusion criteria 7. A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting the definition of CTO (any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (Thrombolysis in Myocardial Infarction (TIMI) score of 0 or 1) and estimated to be in duration of ≥ 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram)
Exclusion criteria
Participants must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedure Success | Through Discharge up to 24 hours post-procedure | Defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE). • MACE defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction (MI) (Q-wave or non-Q-wave, with creatine kinase (CK) with Muscle (M)-Brain (B) subunits \> 3 ULN). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Recanalization. | Through Procedure, up to 4 hours | Defined as angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area. |
| Number of Participants With In-hospital MACE. | Through Discharge up to 24 hours | Defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural MI (Q-wave or non-Q-wave, with CK-MB \> 3 ULN). The components of MACE will also be reported separately. |
| Number of Participants With Clinically Significant Perforation. | Through Procedure up to 4 hours | Defined as any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy. |
| Number of Participants With Procedural Success According to Crossing Technique. | Through Procedure up to 4 hours post-procedure | Procedural success is defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE). |
| Number of Participants With Technical Success. | Through Procedure up to 4 hours post-procedure | Defined as successful guidewire recanalization is applicable to investigational devices as at least one investigational guidewire must be used in every procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.
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.
GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter: GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Chronic Total Occlusion Percutaneous Coronary Intervention |
|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 130 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 150 |
| other Total, other adverse events | 0 / 150 |
| serious Total, serious adverse events | 38 / 150 |
Outcome results
Primary
Number of Participants With Procedure Success
Defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE). • MACE defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction (MI) (Q-wave or non-Q-wave, with creatine kinase (CK) with Muscle (M)-Brain (B) subunits \> 3 ULN).
Time frame: Through Discharge up to 24 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Number of Participants With Procedure Success | 121 Participants |
Secondary
Number of Participants With Clinically Significant Perforation.
Defined as any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy.
Time frame: Through Procedure up to 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Number of Participants With Clinically Significant Perforation. | 16 Participants |
Secondary
Number of Participants With In-hospital MACE.
Defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural MI (Q-wave or non-Q-wave, with CK-MB \> 3 ULN). The components of MACE will also be reported separately.
Time frame: Through Discharge up to 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Number of Participants With In-hospital MACE. | 29 Participants |
Secondary
Number of Participants With Procedural Success According to Crossing Technique.
Procedural success is defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE).
Time frame: Through Procedure up to 4 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Number of Participants With Procedural Success According to Crossing Technique. | 69 Participants |
| Retrograde | Number of Participants With Procedural Success According to Crossing Technique. | 1 Participants |
| Combined Antegrade and Retrograde | Number of Participants With Procedural Success According to Crossing Technique. | 43 Participants |
Secondary
Number of Participants With Successful Recanalization.
Defined as angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.
Time frame: Through Procedure, up to 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Number of Participants With Successful Recanalization. | 142 Participants |
Secondary
Number of Participants With Technical Success.
Defined as successful guidewire recanalization is applicable to investigational devices as at least one investigational guidewire must be used in every procedure.
Time frame: Through Procedure up to 4 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic Total Occlusion Percutaneous Coronary Intervention | Number of Participants With Technical Success. | 140 Participants |