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Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery

NCT06378775 — Not applicable, Not yet recruiting, 80 participants, Cardiology Research UBC
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Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery: a Pilot Trial

RegistryNCT06378775, acronym ROBOT RCT
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment80 (Estimated)
SponsorCardiology Research UBC (Other)
ConditionsCoronary Artery Disease, Multivessel Coronary Artery Disease
InterventionsCoronary Artery Bypass Graft, Robotically-assisted minimally-invasive direct coronary artery bypass, Percutaneous Coronary Intervention (Procedure)
Datesstart 2024-05-01 (estimated), primary completion 2027-05-01 (estimated), completion 2028-12-01 (estimated), first posted 2024-04-22, last updated 2024-04-23

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Hybrid Coronary RevascularizationExperimentalProcedure: Robotically-assisted minimally-invasive direct coronary artery bypass; Procedure: Percutaneous Coronary Intervention2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI)
Coronary Artery Bypass Grafting (CABG)Active comparatorProcedure: Coronary Artery Bypass GraftCoronary Artery Bypass Grafting
  • Coronary Artery Bypass Graft (Procedure), also known as CABG: Coronary Artery Bypass Graft
  • Robotically-assisted minimally-invasive direct coronary artery bypass (Procedure), also known as RA-MIDCAB: Robotically-assisted minimally-invasive direct coronary artery bypass
  • Percutaneous Coronary Intervention (Procedure), also known as PCI: Percutaneous Coronary Intervention

+Outcome measures

Primary outcomes

  • Post-operative Length of Stay [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)]: Rate of intraoperative conversion from RA-MIDCAB to sternotomy CABG (%)

Other outcomes

  • Intubation duration [From end of surgery time to extubation time]: Time to extubation post surgery measured in hours
  • ICU length of stay [From end of surgery time to ICU discharge time, assessed up to 10 days]: Time spent in ICU post-surgery measured in hours

+Eligibility

Sex: All

Inclusion Criteria:

1. Multi-vessel CAD with an indication for revascularization,
2. 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)
3. 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

1. Significant left main coronary artery disease,
2. Ejection fraction < 30%,
3. Patients with GFR < 30,
4. Patients unable to take dual anti-platelet agents due to high bleeding risk,
5. Patients requiring emergent surgery, including patients with hemodynamic instability,
6. Patients with anatomy not suitable for a robotically-assisted approach (by CT chest).

My Notes