Coronary Artery DiseaseROBOT RCTNCT06378775
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery
A study testing Coronary Artery Bypass Graft, Robotically-assisted minimally-invasive direct coronary artery bypass and Percutaneous Coronary Intervention in people with Coronary Artery Disease and Multivessel Coronary Artery Disease, run by Cardiology Research UBC.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Multivessel Coronary Artery Disease
- What is being tested?
- Coronary Artery Bypass Graft, Robotically-assisted minimally-invasive direct coronary artery bypass and Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
About this study
Official title: 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.
- Being tested
- Coronary Artery Bypass Graft, Robotically-assisted minimally-invasive direct coronary artery bypass, Percutaneous Coronary Intervention
- Keywords
- CABG, Hybrid Coronary Revascularization, Robotically-assisted minimally-invasive direct coronary artery bypass, RA-MIDCAB
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass GraftProcedure or surgery
Also called CABG
Coronary Artery Bypass Graft
Robotically-assisted minimally-invasive direct coronary artery bypassProcedure or surgery
Also called RA-MIDCAB
Robotically-assisted minimally-invasive direct coronary artery bypass
Percutaneous Coronary InterventionProcedure or surgery
Also called PCI
Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Coronary Revascularization | Experimental | 2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI) Receives: Procedure: Robotically-assisted minimally-invasive direct coronary artery bypass; Procedure: Percutaneous Coronary Intervention |
| Coronary Artery Bypass Grafting (CABG) | Active comparator | Coronary Artery Bypass Grafting Receives: Procedure: Coronary Artery Bypass Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Length of Stay
Number of days from end of surgery to hospital discharge
Measured: From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days
Secondary outcomes (1)
Conversion to sternotomy / CABG
Rate of intraoperative conversion from RA-MIDCAB to sternotomy CABG (%)
Measured: From beginning of surgery time to end of surgery time (skin to skin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378775
- Sponsor's protocol ID
- H23-03334
- Acronym
- ROBOT RCT
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery: a Pilot Trial
- ClinicalTrials.gov ID
- NCT06378775
- Acronym / sponsor ID
- ROBOT RCT / H23-03334
- Keywords
- CABG, Hybrid Coronary Revascularization, Robotically-assisted minimally-invasive direct coronary artery bypass, RA-MIDCAB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Coronary Revascularization | Experimental | Procedure: Robotically-assisted minimally-invasive direct coronary artery bypass, Procedure: Percutaneous Coronary Intervention2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI) |
| Coronary Artery Bypass Grafting (CABG) | Active comparator | Procedure: Coronary Artery Bypass GraftCoronary Artery Bypass Grafting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Artery Bypass GraftAlso: CABGCoronary Artery Bypass Graft | Procedure or surgery | Coronary Artery Bypass Grafting (CABG) |
| Robotically-assisted minimally-invasive direct coronary artery bypassAlso: RA-MIDCABRobotically-assisted minimally-invasive direct coronary artery bypass | Procedure or surgery | Hybrid Coronary Revascularization |
| Percutaneous Coronary InterventionAlso: PCIPercutaneous Coronary Intervention | Procedure or surgery | Hybrid Coronary Revascularization |
Primary outcome
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
1 secondary outcome
Conversion to sternotomy / CABG
Time frame: From beginning of surgery time to end of surgery time (skin to skin)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Artery Bypass Graft, Robotically-assisted minimally-invasive direct coronary artery bypass and Percutaneous Coronary Intervention in people with Coronary Artery Disease and Multivessel Coronary Artery Disease, run by Cardiology Research UBC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Length of Stay (time frame: From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.