Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-29 @ 7:07 AM
Study NCT ID:
NCT02047266
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2014-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting
Sponsor:
Vitebsk Regional Clinical Hospital
Organization:
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, n=50).
2. OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
3. ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). 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, n=50).
2. OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
3. ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). 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:
True
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?: