Trial Outcomes & Findings for Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs) (NCT NCT00886899)

Results Overview

Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

147 participants

Primary outcome timeframe

Intraprocedural

Results posted on

2012-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	BridgePoint Medical System Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Overall Study STARTED	147
Overall Study COMPLETED	147
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BridgePoint Medical System n=147 Participants Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Age Continuous	63.3 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants
Region of Enrollment United States	147 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraprocedural

Population: Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants.

Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire

Outcome measures

Outcome measures
Measure	BridgePoint Medical System n=150 CTOs Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Technical Success	77 percentage of CTOs Interval 70.0 to 82.0

PRIMARY outcome

Timeframe: 30 Days

Population: Includes 21 patients with "early" (\<30 day) follow-up

Defined as cardiac death, Q-wave and non-Q-wave \[total creatinine kinase (CK) \>2x upper limit of normal with a positive myocardial band (MB) fraction\] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.

Outcome measures

Outcome measures
Measure	BridgePoint Medical System n=147 Participants Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
30-day Major Adverse Cardiac Event (MACE) Rate All participants	4.8 percentage of participants Interval 2.3 to 8.8
30-day Major Adverse Cardiac Event (MACE) Rate Patients with at least 30-days follow-up (n=136)	5.1 percentage of participants Interval 2.5 to 9.5

SECONDARY outcome

Timeframe: Intraprocedural

Population: Procedure time data for two participants was not available.

Minus any time to determine CTO was refractory to standard guidewire

Outcome measures

Outcome measures
Measure	BridgePoint Medical System n=145 Participants Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Total Procedure Time	105 minutes Standard Deviation 54

SECONDARY outcome

Timeframe: Intraprocedural

Population: Fluoroscopy time was not available for two participants

Minus any time to determine CTO was refractory to standard guidewire

Outcome measures

Outcome measures
Measure	BridgePoint Medical System n=145 Participants Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Total Procedural Fluoroscopy Time	44 minutes Standard Deviation 25

Adverse Events

BridgePoint Medical System

Serious events: 25 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BridgePoint Medical System n=147 participants at risk Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Cardiac disorders Death	1.4% 2/147 • Number of events 2
Cardiac disorders Non-Q-Wave Myocardial Infarction (NQWMI)	4.1% 6/147 • Number of events 6
Nervous system disorders Cerebral Vascular Accident/Stroke	0.68% 1/147 • Number of events 1
Vascular disorders Perforation	6.8% 10/147 • Number of events 10
Cardiac disorders Pericardial Effusion	2.0% 3/147 • Number of events 3
Cardiac disorders Arrhythmia Requiring Treatment	3.4% 5/147 • Number of events 5

Other adverse events

Other adverse events
Measure	BridgePoint Medical System n=147 participants at risk Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Cardiac disorders Cardiac Enzyme Elevation	14.3% 21/147 • Number of events 21
Vascular disorders Untreated Dissection	0.68% 1/147 • Number of events 1
Vascular disorders Puncture Site Complication	7.5% 11/147 • Number of events 11
Vascular disorders Non-Target Vessel Treatment	2.0% 3/147 • Number of events 3
Vascular disorders Other	17.0% 25/147 • Number of events 25

Additional Information

VP, Clinical Affairs

BridgePoint Medical

Phone: 763-225-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place