Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating Room

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canada Foundation for Innovation
Ontario Innovative Trust
Ontario Research and Development Challenge Fund
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00366015
First received: August 16, 2006
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Robotic-assisted Coronary Surgical Revascularization
Procedure: PCI- Drug Eluting Stents

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Safety & efficacy of integrated myocardial revascularization performed in a single stage [ Time Frame: 5 years post end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
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)
Intervention Details:
    Procedure: Robotic-assisted Coronary Surgical Revascularization
    Robotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console
    Procedure: PCI- Drug Eluting Stents
    Drug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery
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 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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with class A or B1 low risk coronary artery lesion as defined by TIMI

Exclusion Criteria:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366015

Contacts
Contact: Crystal Watt 519-685-8500 ext 33153 Crystal.Watt@lhsc.on.ca

Locations
Canada, Ontario
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         
Sponsors and Collaborators
Lawson Health Research Institute
Canada Foundation for Innovation
Ontario Innovative Trust
Ontario Research and Development Challenge Fund
Investigators
Principal Investigator: Bob Kiaii, MD, FRCSC Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
  More Information

Publications:

Responsible Party: Dr. Bob Kiaii, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00366015     History of Changes
Other Study ID Numbers: R-04-158, 9874
Study First Received: August 16, 2006
Last Updated: August 3, 2011
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Coronary Artery Disease
PCI
Drug eluting stents
Coronary Hybrid Revascularization
Robotic CABG

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014