Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366015
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2006-08-16
Brief Title:
Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating Room
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Same Procedure Cardiac Hybrid Surgery in a Specialty Built OR-- A Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 diseasecoronary 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9874 | OTHER | REB | None |