Trial Outcomes & Findings for Chronic Total Occlusion Percutaneous Coronary Intervention Study (NCT NCT03988166)
NCT ID: NCT03988166
Last Updated: 2022-09-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Through Discharge up to 24 hours post-procedure
Results posted on
2022-09-28
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
147
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Chronic Total Occlusion Percutaneous Coronary Intervention Study
Baseline characteristics by cohort
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=150 Participants
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
|
|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Through Discharge up to 24 hours post-procedureDefined 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).
Outcome measures
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=150 Participants
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
|
Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using the retrograde approach/technique.
|
Combined Antegrade and Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using both antegrade and retrograde approaches/techniques.
|
|---|---|---|---|
|
Number of Participants With Procedure Success
|
121 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Procedure, up to 4 hoursDefined as angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.
Outcome measures
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=150 Participants
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
|
Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using the retrograde approach/technique.
|
Combined Antegrade and Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using both antegrade and retrograde approaches/techniques.
|
|---|---|---|---|
|
Number of Participants With Successful Recanalization.
|
142 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Discharge up to 24 hoursDefined 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.
Outcome measures
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=150 Participants
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
|
Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using the retrograde approach/technique.
|
Combined Antegrade and Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using both antegrade and retrograde approaches/techniques.
|
|---|---|---|---|
|
Number of Participants With In-hospital MACE.
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Procedure up to 4 hoursDefined as any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy.
Outcome measures
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=150 Participants
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
|
Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using the retrograde approach/technique.
|
Combined Antegrade and Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using both antegrade and retrograde approaches/techniques.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Perforation.
|
16 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Procedure up to 4 hours post-procedureProcedural 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).
Outcome measures
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=81 Participants
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
|
Retrograde
n=2 Participants
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using the retrograde approach/technique.
|
Combined Antegrade and Retrograde
n=67 Participants
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using both antegrade and retrograde approaches/techniques.
|
|---|---|---|---|
|
Number of Participants With Procedural Success According to Crossing Technique.
|
69 Participants
|
1 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Through Procedure up to 4 hours post-procedureDefined as successful guidewire recanalization is applicable to investigational devices as at least one investigational guidewire must be used in every procedure.
Outcome measures
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=150 Participants
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
|
Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using the retrograde approach/technique.
|
Combined Antegrade and Retrograde
CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used using both antegrade and retrograde approaches/techniques.
|
|---|---|---|---|
|
Number of Participants With Technical Success.
|
140 Participants
|
—
|
—
|
Adverse Events
Chronic Total Occlusion Percutaneous Coronary Intervention
Serious events: 38 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Chronic Total Occlusion Percutaneous Coronary Intervention
n=150 participants at risk
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
|
|---|---|
|
Cardiac disorders
Myocardial Infarction (MI)
|
18.0%
27/150 • Number of events 27 • Collection of Adverse Events (AE) occurred after enrollment through end of the study participation (30-days)
|
|
Cardiac disorders
Myocardial Infarction
|
6.0%
9/150 • Number of events 9 • Collection of Adverse Events (AE) occurred after enrollment through end of the study participation (30-days)
|
|
Cardiac disorders
Death
|
0.67%
1/150 • Number of events 1 • Collection of Adverse Events (AE) occurred after enrollment through end of the study participation (30-days)
|
|
Cardiac disorders
Target Lesion Revascularization
|
0.67%
1/150 • Number of events 1 • Collection of Adverse Events (AE) occurred after enrollment through end of the study participation (30-days)
|
Other adverse events
Adverse event data not reported
Additional Information
Ricardo De Medeiros, Director Scientific Clinical Affairs
Teleflex
Phone: 612.812.5008
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60