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

April 21, 2024 updated by: Cardiology Research UBC

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Coronary Artery Bypass Grafting (CABG)
Coronary Artery Bypass Grafting
Procedure: Coronary Artery Bypass Graft
Coronary Artery Bypass Graft
Other Names:
  • CABG
Experimental: Hybrid Coronary Revascularization
2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI)
Procedure: Percutaneous Coronary Intervention
Percutaneous Coronary Intervention
Other Names:
  • PCI
Procedure: Robotically-assisted minimally-invasive direct coronary artery bypass
Robotically-assisted minimally-invasive direct coronary artery bypass
Other Names:
  • RA-MIDCAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)
From beginning of surgery time to end of surgery time (skin to skin)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation duration
Time Frame: From end of surgery time to extubation time
Time to extubation post surgery measured in hours
From end of surgery time to extubation time
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
From end of surgery time to ICU discharge time, assessed up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiology Research UBC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23-03334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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