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

Same Procedure Cardiac Hybrid Surgery in a Specialty Built OR-- A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00366015
Enrollment
80
Registered
2006-08-18
Start date
2003-07-29
Completion date
2010-12-31
Last updated
2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease, PCI, Drug eluting stents, Coronary Hybrid Revascularization, Robotic CABG

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. 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.

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.

Interventions

PROCEDURERobotic-assisted Coronary Surgical Revascularization

Robotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console

PROCEDUREPCI- Drug Eluting Stents

Drug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery

Sponsors

Canada Foundation for Innovation
CollaboratorOTHER
Ontario Innovative Trust
CollaboratorUNKNOWN
Ontario Research and Development Challenge Fund
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety & efficacy of integrated myocardial revascularization performed in a single stage5 years post end of study

Secondary

MeasureTime frame
One-year postoperative stenosis rate (Stenosis may be evaluated by the angiographic documentation of blood flow).One year
Success rate is defined as a reduction in stenosis to < 50%.One year
Myocardial infarction,within 30 days of surgery
Death,within 30 days of surgery and/or within primary hospitalization
Repeat revascularization at any time after the robotic hybrid revascularization (Repeat revascularization are those involving a previously treated lesionfollowing the initial hybrid procedure)One year
In-hospital complications during or after surgery,within initial hospitalization or within 30 days of discharge
Inability to revascularize with the use of both stenting and LIMA to LAD bypass,within initial hospitalization
Inability to revascularize with the use of the da Vinci Surgical Systemwithin initial hospitalization

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026