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

Cardiology Research UBC

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Multivessel Coronary Artery Disease

Treatments: Procedure: Percutaneous Coronary Intervention; Procedure: Robotically-assisted minimally-invasive direct coronary artery bypass; Procedure: Coronary Artery Bypass Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06378775

H23-03334

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Hybrid Coronary Revascularization

Experimental group

Description:

2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI)

Treatment:

Procedure: Robotically-assisted minimally-invasive direct coronary artery bypass

Procedure: Percutaneous Coronary Intervention

Coronary Artery Bypass Grafting (CABG)

Active Comparator group

Description:

Coronary Artery Bypass Grafting

Treatment:

Procedure: Coronary Artery Bypass Graft