Loading clinical trials...

Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

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

NCT06378775•Cardiology Research UBC

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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).

Key Dates

Start Date

May 1, 2024

Primary Completion Date

May 1, 2027

Completion Date

December 1, 2028

Last Updated

April 23, 2024

Enrollment

ESTIMATED participants

Conditions

Coronary Artery DiseaseMultivessel Coronary Artery Disease

Interventions

Coronary Artery Bypass Graft

PROCEDURE

Robotically-assisted minimally-invasive direct coronary artery bypass

PROCEDURE

Percutaneous Coronary Intervention

PROCEDURE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Coronary Artery Disease

View study

RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

Product Surveillance Registry

Essential Pro Study ( rEPIC04E-HK )

Factors Affect Outcomes in Cardiovascular Surgery