Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary Artery Bypass Graft, Robotically-assisted minimally-invasive direct coronary artery bypass, Percutaneous Coronary Intervention.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Multivessel Coronary Artery Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery: a Pilot Trial
Overview
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.
Interventions
- Procedure Coronary Artery Bypass Graft
Coronary Artery Bypass Graft - Procedure Robotically-assisted minimally-invasive direct coronary artery bypass
Robotically-assisted minimally-invasive direct coronary artery bypass - Procedure Percutaneous Coronary Intervention
Percutaneous Coronary Intervention
Primary outcome measures
- Post-operative Length of Stay [Time frame: From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days]
Secondary outcome measures (1)
- Conversion to sternotomy / CABG [Time frame: From beginning of surgery time to end of surgery time (skin to skin)]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06378775 · H23-03334