Ignite Creation Date:
2024-05-06 @ 2:26 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02047266
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2014-01-19
Brief Title:
Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting
Sponsor:
Vitebsk Regional Clinical Hospital
Organization:
Vitebsk Regional Clinical Hospital
Study Overview
Official Title:
Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting MICS CABG Versus Off Pump OPCABG and on Pump Coronary Artery Bypass Grafting ONCABG in Patients With Multi-vessel Coronary Disease
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
RECRUITING
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:
The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease MICS CABG OPCABG and ONCABG
The study hypothesis MICS CABG Minimally invasive cardiac surgery coronary artery bypass grafting has advantages in comparison with conventional off-pump OPCABG and on-pump coronary artery bypass grafting ONCABG concerning major adverse cardiac and cerebral events MACCE and procedural success
The study hypothesis MICS CABG Minimally invasive cardiac surgery coronary artery bypass grafting has advantages in comparison with conventional off-pump OPCABG and on-pump coronary artery bypass grafting ONCABG concerning major adverse cardiac and cerebral events MACCE and procedural success
Detailed Description:
Prospective single-center randomized trial intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease
1 MICS CABG Minimally invasive cardiac surgery coronary artery bypass grafting complete multivessel minimally invasive off-pump revascularization via left minithoracotomy MICS CABG group n50
2 OPCABG Off-pump coronary artery bypass grafting treatment OPCABG group n50
3 ONCABG On-pump coronary artery bypass grafting treatment ONCABG group n50 The endpoints The primary endpoints will be death MI stroke or new myocardial ischemia and will be target vessel revascularization and non-target vessel revascularization at 30 days 12 months and 3-year follow-up
The secondary endpoints Procedural success Procedural and post-procedural blood loss and number of transfusions Wound complications Recovery time Heart Failure New York Heart Association NYHA Life quality assessed by one of the life quality questionnaires
1 MICS CABG Minimally invasive cardiac surgery coronary artery bypass grafting complete multivessel minimally invasive off-pump revascularization via left minithoracotomy MICS CABG group n50
2 OPCABG Off-pump coronary artery bypass grafting treatment OPCABG group n50
3 ONCABG On-pump coronary artery bypass grafting treatment ONCABG group n50 The endpoints The primary endpoints will be death MI stroke or new myocardial ischemia and will be target vessel revascularization and non-target vessel revascularization at 30 days 12 months and 3-year follow-up
The secondary endpoints Procedural success Procedural and post-procedural blood loss and number of transfusions Wound complications Recovery time Heart Failure New York Heart Association NYHA Life quality assessed by one of the life quality questionnaires
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