Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating Room
Recruitment status was Recruiting
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. Two previously approved and commonly performed procedures used to treat coronary artery disease(coronary stenting and robotic bypass surgery) are being combined into a hybrid surgery in a specialty built operating room. Patients with low risk coronary lesions will undergo cardiac hybrid revascularization using stenting and LIMA to LAD robotic bypass concomitantly. Patients' postoperative bleeding rates, angiographs and complication free rates will be recorded.
Coronary Artery Disease
Procedure: Robotic-assisted Coronary Surgical Revascularization
Procedure: PCI- Drug Eluting Stents
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Same Procedure Cardiac Hybrid Surgery in a Specialty Built OR-- A Pilot Study|
- Safety & efficacy of integrated myocardial revascularization performed in a single stage [ Time Frame: 5 years post end of study ] [ Designated as safety issue: Yes ]
- One-year postoperative stenosis rate (Stenosis may be evaluated by the angiographic documentation of blood flow). [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Success rate is defined as a reduction in stenosis to < 50%. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Myocardial infarction, [ Time Frame: within 30 days of surgery ] [ Designated as safety issue: Yes ]
- Death, [ Time Frame: within 30 days of surgery and/or within primary hospitalization ] [ Designated as safety issue: Yes ]
- Repeat revascularization at any time after the robotic hybrid revascularization (Repeat revascularization are those involving a previously treated lesionfollowing the initial hybrid procedure) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- In-hospital complications during or after surgery, [ Time Frame: within initial hospitalization or within 30 days of discharge ] [ Designated as safety issue: Yes ]
- Inability to revascularize with the use of both stenting and LIMA to LAD bypass, [ Time Frame: within initial hospitalization ] [ Designated as safety issue: Yes ]
- Inability to revascularize with the use of the da Vinci Surgical System [ Time Frame: within initial hospitalization ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Procedure: Robotic-assisted Coronary Surgical Revascularization
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 perceptible until the condition has advanced to a severe and serious stage, which might explain the large mortality and morbidity rates associated with heart disease.
At this point there are many procedures available to treat CAD all of which aim to improve myocardial blood flow, stop angina, increase exercise ability and ultimately free patients from medications and improve their quality of life. Medications are used to reduce blood pressure and relieve strain on the heart. Cardiologists use angioplasty, which compresses plaque deposits, and stenting, in which a small wire mesh tube is inserted into the diseased artery to revascularize the heart muscle. On-pump coronary artery bypass grafting (CABG) redirects blood flow around clogged vessels of the heart and is commonly used by cardiac surgeons to treat CAD because it has been proven to yield the lowest restenosis rate of all revascularization techniques (Cisowski, 2002). CABG is an effective yet painful and traumatic intervention.
The desire to discover a less distressing approach to coronary artery revascularization has led to a fairly new cardiac hybrid procedure that involves stenting followed by a minimally invasive left internal mammary artery (LIMA) to left anterior descending artery (LAD) bypass graft (Amodeo, 2002). The hybrid procedure for revascularization carries a lower morbidity than does on-pump CABG and is also quickly gaining acceptance in the surgical community (de Canniere et al, 2001). The two procedures of hybrid revascularization are currently performed within 24 to 48 hours of each other with little collaboration between cardiac surgeons and cardiologist.
This study will asses the efficacy and safety of cardiac hybrid surgery that combines stenting and robotic LIMA to LAD grafting in the same procedure in a specialty built operating room. Long term use of the antiplatelet inhibitor, clopidogrel, to be taken by patients in this study, was proven to significantly reduce the risk of adverse ischemic events after percutaneous coronary interventions (Steinhubl, 2002). In addition, the application of Bivalirudin (Direct Thrombin Inhibitor) will be assessed in this integrated myocardial revascularization scenario. The many attractive aspects of robotic hybrid bypass include the avoidance of the procedural phases (arrested heart, blood transfusion, median sternotomy and cardiopulmonary bypass) of on-pump CABG. Robotic LIMA to LAD bypass and stenting in the same procedure will allow cardiac surgeons and cardiologists to work together to help patients obtain safe and effective coronary artery revascularization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366015
|Contact: Crystal Watt||519-685-8500 ext 33153||Crystal.Watt@lhsc.on.ca|
|The London Health Sciences Centre, University Hospital||Recruiting|
|London, Ontario, Canada, N6A 5A5|
|Sub-Investigator: Dave Almond, MD|
|Sub-Investigator: Bill Kostuk, MD|
|Sub-Investigator: Kumar Sridhar, MD|
|Sub-Investigator: Patrick Teefy, MD|
|Sub-Investigator: Reiza Rayman, MD|
|Sub-Investigator: Stuart Swinamer, MD|
|Principal Investigator:||Bob Kiaii, MD, FRCSC||Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital|