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NCT Number: NCT06378775

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

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Multivessel Coronary Artery Disease Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Coronary artery bypass graft

Procedure

Coronary Artery Bypass Graft

Other names: CABG

Robotically-assisted minimally-invasive direct coronary artery bypass

Procedure

Robotically-assisted minimally-invasive direct coronary artery bypass

Other names: RA-MIDCAB

Percutaneous coronary intervention

Procedure

Percutaneous Coronary Intervention

Other names: PCI

Primary outcomes

  1. Post-operative Length of Stay

    Time frame: 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

  1. Conversion to sternotomy / CABG

    Time frame: 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

  1. Intubation duration

    Time frame: From end of surgery time to extubation time

    Time to extubation post surgery measured in hours

  2. ICU length of stay

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

    Time spent in ICU post-surgery measured in hours

Sponsors and collaborators

Lead sponsor

Cardiology Research UBC

Other

Registry information

Official study title

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

Acronym: ROBOT RCT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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