Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions (PCI) (NCT NCT01275092)

Results Overview

Defined as \<30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

164 participants

Primary outcome timeframe

48-hrs or hospital discharge, whichever occurs first

Results posted on

2013-08-08

Participant Flow

During January-December 2011 period 164 participants were enrolled in the PRECISE study at 9 clinical sites

Participant milestones

Participant milestones
Measure	CorPath Robotic-assisted PCI CorPath 200 robotic-assisted PCI
Overall Study STARTED	164
Overall Study COMPLETED	164
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions (PCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CorPath Robotic-assisted PCI n=164 Participants CorPath 200 robotic-assisted PCI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=5 Participants
Age, Categorical >=65 years	77 Participants n=5 Participants
Age Continuous	64.1 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants
Region of Enrollment United States	144 participants n=5 Participants
Region of Enrollment Colombia	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 48-hrs or hospital discharge, whichever occurs first

Defined as \<30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.

Outcome measures

Outcome measures
Measure	CorPath Robotic-assisted PCI n=164 Participants CorPath 200 robotic-assisted PCI
Percentage of Participants With Clinical Procedural Success	97.6 percentage of participants Interval 94.5 to 100.0

PRIMARY outcome

Timeframe: 1 day

Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.

Outcome measures

Outcome measures
Measure	CorPath Robotic-assisted PCI n=164 Participants CorPath 200 robotic-assisted PCI
Percentage of Patients With Device Technical Success	98.8 percentage of participants Interval 96.2 to 100.0

SECONDARY outcome

Timeframe: 1 day

Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.

Outcome measures

Outcome measures
Measure	CorPath Robotic-assisted PCI n=164 Participants CorPath 200 robotic-assisted PCI
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table	0.42 ratio Interval 0.0 to 4.5

Adverse Events

CorPath Robotic-assisted PCI

Serious events: 28 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CorPath Robotic-assisted PCI n=164 participants at risk CorPath 200 robotic-assisted PCI
Vascular disorders cardiovascular complications	16.5% 27/164 • Number of events 28 • 1 month
General disorders Others	0.61% 1/164 • Number of events 5 • 1 month

Other adverse events

Other adverse events
Measure	CorPath Robotic-assisted PCI n=164 participants at risk CorPath 200 robotic-assisted PCI
Vascular disorders Cardiovascular complications	15.9% 26/164 • Number of events 26 • 1 month
General disorders Others	22.0% 36/164 • Number of events 36 • 1 month

Additional Information

Giora Weisz, MD; Director of Clinical Resarch Center for Interven tional Vascular Therapy

Columbia University Medical Center, New York, NY, 10032

Phone: 212-305-7060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60