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

• ClinicalTrials.gov Identifier: NCT01076036
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Results First Posted: September 7, 2015
• Last Update Posted: September 7, 2015
• Sponsor: Corindus Inc.
• Information provided by (Responsible Party): Corindus Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Artery Disease
• Intervention: Device: CorPath 200
• Enrollment: 8

Participant Flow

Recruitment Details	February-March 2011 at CORBIC, Envigado, Colombia
Pre-assignment Details

Arm/Group Title	Group 1
Arm/Group Description	Group 1 was treated using the CorPath device.
Period Title: Overall Study
Started	10
# of Procedures	8
Complete CorPath Procedures	8
Completed	8
Not Completed	2
Reason Not Completed
Didn't meet inclusion/exclusion criteria	2

Baseline Characteristics

Arm/Group Title		Investigational
Arm/Group Description		CorPath® 200 System
Overall Number of Baseline Participants		8
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	3 37.5%
	>=65 years	5 62.5%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	8 participants
		67.8 (10.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants
	Female	5 62.5%
	Male	3 37.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Colombia	Number Analyzed	8 participants
		8

Outcome Measures

1. Primary Outcome

Title	Clinical Procedural Success
Description	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)
Time Frame	48-hrs or hospital discharge, whichever occurs first

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigational
Arm/Group Description:	CorPath® 200 System
Overall Number of Participants Analyzed	8
Measure Type: Number; Unit of Measure: percentage of participants
	100

2. Primary Outcome

Title	Procedural Technical Success
Description	Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.
Time Frame	Intervention

Outcome Measure Data

Analysis Population Description

Total number of PCI devices.

Arm/Group Title	Investigational
Arm/Group Description:	CorPath® 200 System
Overall Number of Participants Analyzed	8
Measure Type: Number; Unit of Measure: percentage of PCI devices
	97.8

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Investigational
Arm/Group Description	CorPath® 200 System
All-Cause Mortality
	Investigational
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Investigational
	Affected / at Risk (%)
Total	0/8 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Investigational
	Affected / at Risk (%)
Total	0/8 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Michail M. Pankratov, MD, PhD, Vice President of Clinical & Regulatory Affairs
• Organization: Corindus, Inc
• Phone: 508-653-3335 ext 206
• EMail: Michail.Pankratov@Corindus.com

• Responsible Party: Corindus Inc.
• ClinicalTrials.gov Identifier: NCT01076036
• Other Study ID Numbers: Corindus-Corbic-2010
• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Results First Submitted: July 31, 2012
• Results First Posted: September 7, 2015
• Last Update Posted: September 7, 2015