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Clinical Trials/NCT06378775
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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
December 1, 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cardiology Research UBC
Responsible Party
Sponsor

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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