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

NCT06378775 | Not Yet Recruiting DMC

• 1 other identifier: H23-03334
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Multivessel Coronary Artery Disease

Keywords

CABG; Hybrid Coronary Revascularization; Robotically-assisted minimally-invasive direct coronary artery bypass; RA-MIDCAB

Outcome Measures

Primary Outcomes (1)

• Post-operative Length of Stay

  Number of days from end of surgery to hospital discharge

  From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days

Secondary Outcomes (1)

• Conversion to sternotomy / CABG

  From beginning of surgery time to end of surgery time (skin to skin)

Other Outcomes (2)

• Intubation duration

  From end of surgery time to extubation time

• ICU length of stay

  From end of surgery time to ICU discharge time, assessed up to 10 days

Study Arms (2)

Hybrid Coronary Revascularization

EXPERIMENTAL

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

Procedure: Robotically-assisted minimally-invasive direct coronary artery bypass; Procedure: Percutaneous Coronary Intervention

Coronary Artery Bypass Grafting (CABG)

ACTIVE COMPARATOR

Coronary Artery Bypass Grafting

Procedure: Coronary Artery Bypass Graft

Interventions

Coronary Artery Bypass Graft PROCEDURE

Coronary Artery Bypass Graft

Also known as: CABG

Coronary Artery Bypass Grafting (CABG)

Robotically-assisted minimally-invasive direct coronary artery bypass PROCEDURE

Robotically-assisted minimally-invasive direct coronary artery bypass

Also known as: RA-MIDCAB

Hybrid Coronary Revascularization

Percutaneous Coronary Intervention PROCEDURE

Percutaneous Coronary Intervention

Also known as: PCI

Hybrid Coronary Revascularization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cardiology Research UBC: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Endovascular Procedures; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04