Status:
COMPLETED
Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating Room
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Canada Foundation for Innovation
Ontario Innovative Trust
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
30-85 years
Phase:
NA
Brief Summary
This study will combine coronary stenting with minimally invasive robotic coronary bypass surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded coronary arteries....
Detailed Description
Coronary artery disease (CAD) is the leading cause of death in the United States and becomes more common as the population ages (American Heart Association, 2003). The symptoms of CAD may not become p...
Eligibility Criteria
Inclusion
- Patients with class A or B1 low risk coronary artery lesion as defined by TIMI
Exclusion
- Contraindications to PCI which include:
- Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels \<1.5mm
- Contraindications to Robotic Surgery which include:
- Buried LAD, Unable to tolerate single lung ventilation, Inability to undergo beating heart surgery, Previous surgery of the left chest cavity, Lack of intrathoracic work space, Patients requiring emergency surgery,
- The following patients are also excluded:
- Patients with coagulation disorders; inability to tolerate GIIb/III inhibitors, Patients with ventricular arrhythmias, Patients with severe non-cardiac conditions with poor prognosis, Patients with a BMI \>40, Patients with an ejection fraction of \<30%, Patients with chronic renal insufficiency and creatinine \>200umol/L, Patients who are \>85 years of age, Patients participating in any other investigational device or study drug, Patients who have had previous thoracic surgery, Patients who have a pre-op intra-aortic balloon pump, Patients who are not able to follow the protocol requirements, Patients undergoing concomitant surgery; CABG + Valve surgery
Key Trial Info
Start Date :
July 29 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00366015
Start Date
July 29 2003
End Date
December 31 2010
Last Update
August 28 2017
Active Locations (1)
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1
The London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5