Status:
UNKNOWN
Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery
Lead Sponsor:
Mohammed Farouk Abdel Hafez
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
the aim of this study is to evaluate safety and efficacy of multivessel minimally invasive coronary artery bypass graft surgery through evaluating the possibility of reaching complete revascularizatio...
Detailed Description
Minimally invasive direct coronary artery bypass (MIDCAB) grafting can achieve adequate coronary artery revascularization in a less invasive manner than conventional coronary artery bypass grafting (C...
Eligibility Criteria
Inclusion
- Age 18 or more
- Angiographically Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)
- Willing and able to provide written informed consent and comply with study requirements and accepting the need of conversion if needed.
- Patient is willing to comply with all follow-up visits
Exclusion
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment.
- Prior surgery with the opening of pericardium or pleura.
- Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects.
- Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization.
- Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting).
- Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition.
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
- Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
- Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
- Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age.
- Patient inaccessible for follow-up visits required by protocol.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03247855
Start Date
September 1 2017
End Date
October 1 2019
Last Update
August 14 2017
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