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

Coronary Artery Disease Clinical Trial

— ROBOT RCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378775
• Other study ID #: H23-03334
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2028

Study information

• Verified date: April 2024
• Source: Cardiology Research UBC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardiology Research UBC

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intubation duration	Time to extubation post surgery measured in hours	From end of surgery time to extubation time
Other	ICU length of stay	Time spent in ICU post-surgery measured in hours	From end of surgery time to ICU discharge time, assessed up to 10 days
Primary	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	Conversion to sternotomy / CABG	Rate of intraoperative conversion from RA-MIDCAB to sternotomy CABG (%)	From beginning of surgery time to end of surgery time (skin to skin)