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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2028-12-01

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Disease Multivessel Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hybrid Coronary Revascularization

2 Step revascularization: Robotically-assisted minimally-invasive direct coronary artery bypass (RA-MIDCAB) followed by Percutaneous Coronary Intervention (PCI)

Group Type EXPERIMENTAL

Robotically-assisted minimally-invasive direct coronary artery bypass

Intervention Type PROCEDURE

Robotically-assisted minimally-invasive direct coronary artery bypass

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Percutaneous Coronary Intervention

Coronary Artery Bypass Grafting (CABG)

Coronary Artery Bypass Grafting

Group Type ACTIVE_COMPARATOR

Coronary Artery Bypass Graft

Intervention Type PROCEDURE

Coronary Artery Bypass Graft

Interventions

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Coronary Artery Bypass Graft

Intervention Type PROCEDURE

Robotically-assisted minimally-invasive direct coronary artery bypass

Intervention Type PROCEDURE

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Other Intervention Names

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CABG RA-MIDCAB PCI

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No