Trial Outcomes & Findings for CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI) (NCT NCT01076036)

Results Overview

The percentage of Participants with \<30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

48-hrs or hospital discharge, whichever occurs first

Results posted on

2015-09-07

Participant Flow

February-March 2011 at CORBIC, Envigado, Colombia

Participant milestones

Participant milestones
Measure	Group 1 Group 1 was treated using the CorPath device.
Overall Study STARTED	10
Overall Study # of Procedures	8
Overall Study Complete CorPath Procedures	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Group 1 was treated using the CorPath device.
Overall Study Didn't meet inclusion/exclusion criteria	2

Baseline Characteristics

CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational n=8 Participants CorPath® 200 System
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	67.8 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Colombia	8 participants n=5 Participants

PRIMARY outcome

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

The percentage of Participants with \<30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)

Outcome measures

Outcome measures
Measure	Investigational n=8 Participants CorPath® 200 System
Clinical Procedural Success	100 percentage of participants

PRIMARY outcome

Timeframe: Intervention

Population: Total number of PCI devices.

Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.

Outcome measures

Outcome measures
Measure	Investigational n=8 Participants CorPath® 200 System
Procedural Technical Success	97.8 percentage of PCI devices

Adverse Events

Investigational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michail M. Pankratov, MD, PhD, Vice President of Clinical & Regulatory Affairs

Corindus, Inc

Phone: 508-653-3335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place