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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Multivessel Coronary Artery Disease
• Interventions: Procedure: Robotically-assisted minimally-invasive direct coronary artery bypass; Procedure: Coronary Artery Bypass Graft; Procedure: Percutaneous Coronary Intervention

• Registration Number: NCT06378775
• Lead Sponsor: Cardiology Research UBC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-12
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-21
• Study First Posted: 2024-04-22
• Last Update Posted: 2024-04-23
• Study Start: 2024-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Coronary Revascularization	Robotically-assisted minimally-invasive direct coronary artery bypass	2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI)
Coronary Artery Bypass Grafting (CABG)	Coronary Artery Bypass Graft	Coronary Artery Bypass Grafting
Hybrid Coronary Revascularization	Percutaneous Coronary Intervention	2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (%)