Trial Outcomes & Findings for Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions (NCT NCT03901079)
NCT ID: NCT03901079
Last Updated: 2023-12-08
Results Overview
6 subjects have the results data, and 5 of them (83.3%) reported technical success. One (16.7%) failed.
Recruitment status
TERMINATED
Target enrollment
20 participants
Primary outcome timeframe
Subject follow up will occur via telephone contact or clinic visit at 30 days,6 and 12 months post index procedure.
Results posted on
2023-12-08
Participant Flow
Participant milestones
| Measure |
CTO BridgePoint System
BridgePoint CTO System:
* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire
single-arm study: single-arm study
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
CTO BridgePoint System
BridgePoint CTO System:
* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire
single-arm study: single-arm study
|
|---|---|
|
Overall Study
8 of the 20 subjects already enrolled were unable to complete the the 12-month follow-up
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CTO BridgePoint System
n=20 Participants
BridgePoint CTO System:
* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire single-arm study: single-arm study
|
|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 9.4 • n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
|
Current diabetes mellitus
Yes
|
4 Participants
n=20 Participants
|
|
Current diabetes mellitus
No
|
16 Participants
n=20 Participants
|
|
History of hyperlipidemia requiring medication
Yes
|
18 Participants
n=20 Participants
|
|
History of hyperlipidemia requiring medication
No
|
2 Participants
n=20 Participants
|
|
History of hypertension requiring medication
Yes
|
9 Participants
n=20 Participants
|
|
History of hypertension requiring medication
No
|
11 Participants
n=20 Participants
|
|
Family history of coronary artery disease
Yes
|
3 Participants
n=20 Participants
|
|
Family history of coronary artery disease
No
|
16 Participants
n=20 Participants
|
|
Family history of coronary artery disease
Unknown
|
1 Participants
n=20 Participants
|
|
History of Myocardial Infarction (MI)
Yes
|
3 Participants
n=20 Participants
|
|
History of Myocardial Infarction (MI)
No
|
17 Participants
n=20 Participants
|
|
History of congestive heart failure
Yes
|
0 Participants
n=20 Participants
|
|
History of congestive heart failure
No
|
20 Participants
n=20 Participants
|
|
Current anginal status
None
|
6 Participants
n=20 Participants
|
|
Current anginal status
Stable angina
|
5 Participants
n=20 Participants
|
|
Current anginal status
Unstable angina
|
8 Participants
n=20 Participants
|
|
Current anginal status
Unknown
|
1 Participants
n=20 Participants
|
|
Does Subject have silent ischemia
Yes
|
0 Participants
n=20 Participants
|
|
Does Subject have silent ischemia
No
|
20 Participants
n=20 Participants
|
|
History of Percutaneous Coronary Intervention (PCI)
Yes
|
8 Participants
n=20 Participants
|
|
History of Percutaneous Coronary Intervention (PCI)
No
|
12 Participants
n=20 Participants
|
|
History of Coronary Artery Bypass Graft (CABG) surgery
Yes
|
0 Participants
n=20 Participants
|
|
History of Coronary Artery Bypass Graft (CABG) surgery
No
|
19 Participants
n=20 Participants
|
|
History of Coronary Artery Bypass Graft (CABG) surgery
Unknown
|
1 Participants
n=20 Participants
|
|
History of arrhythmia
Yes
|
1 Participants
n=20 Participants
|
|
History of arrhythmia
No
|
19 Participants
n=20 Participants
|
|
Left Ventricular Ejection Fraction (LVEF) measured
Yes
|
19 Participants
n=20 Participants
|
|
Left Ventricular Ejection Fraction (LVEF) measured
No
|
1 Participants
n=20 Participants
|
|
History of cardiogenic shock
Yes
|
0 Participants
n=20 Participants
|
|
History of cardiogenic shock
No
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Subject follow up will occur via telephone contact or clinic visit at 30 days,6 and 12 months post index procedure.Population: Only 6 subjects have the results of technical success or not.
6 subjects have the results data, and 5 of them (83.3%) reported technical success. One (16.7%) failed.
Outcome measures
| Measure |
CTO BridgePoint System
n=6 Participants
BridgePoint CTO System:
* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire
single-arm study: single-arm study
|
|---|---|
|
Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals
Success
|
5 Participants
|
|
Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals
Failed
|
1 Participants
|
Adverse Events
CTO BridgePoint System
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTO BridgePoint System
n=20 participants at risk
BridgePoint CTO System:
* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire
single-arm study: single-arm study
|
|---|---|
|
Cardiac disorders
Coronary artery atherosclerotic heart disease
|
20.0%
4/20 • Number of events 4 • Baseline,30 days, 6 months and 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place