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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details February-March 2011 at CORBIC, Envigado, Colombia
Pre-assignment Details  
Arm/Group Title Group 1
Hide 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
Arm/Group Title Investigational
Hide Arm/Group Description CorPath® 200 System
Overall Number of Baseline Participants 8
Hide 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
1.Primary Outcome
Title Clinical Procedural Success
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational
Hide 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
Hide Description Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.
Time Frame Intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of PCI devices.
Arm/Group Title Investigational
Hide Arm/Group Description:
CorPath® 200 System
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of PCI devices
97.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Investigational
Hide Arm/Group Description CorPath® 200 System
All-Cause Mortality
Investigational
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Investigational
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Investigational
Affected / at Risk (%)
Total   0/8 (0.00%) 
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
Layout table for Results Point of Contact information
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
Layout table for additonal information
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