NCT06378775
Not yet recruiting
Not Applicable
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery: a Pilot Trial
Cardiology Research UBC0 sites80 target enrollmentMay 1, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Cardiology Research UBC
- Enrollment
- 80
- Primary Endpoint
- Post-operative Length of Stay
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Multi-vessel CAD with an indication for revascularization,
- •Presence of at least 1 risk factor for increased risk of post-operative death or major complication,
- •Any patient Age \> 80, OR
- •Any patient with eGFR (Glomerular Filtration Rate) \< 50, OR
- •Any patient with LVEF \< 40%, OR
- •Any patient deemed to be "frail" by consulting surgeon. OR
- •Patients \> 75 years of age with at least one of the following:
- •Ejection fraction \< 50%
- •History of prior CVA (Cerebral Vascular Accident)
- •Coronary artery anatomy appropriate for a robotically-assisted MIDCAB or regular CABG, vessels other than the left anterior descending with lesions amenable to either CABG or PCI.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Post-operative Length of Stay
Time Frame: From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days
Number of days from end of surgery to hospital discharge
Secondary Outcomes
- Conversion to sternotomy / CABG(From beginning of surgery time to end of surgery time (skin to skin))
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