Health TrialsbyHealthPanel

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

ConditionsCoronary Artery DiseaseMultivessel Coronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCardiology Research UBC

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronary Artery Bypass Graft

    Procedure/Surgery

    Coronary Artery Bypass Graft

  • Robotically-assisted minimally-invasive direct coronary artery bypass

    Procedure/Surgery

    Robotically-assisted minimally-invasive direct coronary artery bypass

  • Percutaneous Coronary Intervention

    Procedure/Surgery

    Percutaneous Coronary Intervention

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Hybrid Coronary RevascularizationExperimental treatment 2 interventions
Group B: Coronary Artery Bypass Grafting (CABG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative Length of Stay

Number of days from end of surgery to hospital discharge

Time frame
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 (%)

Time frame
From beginning of surgery time to end of surgery time (skin to skin)

Other outcomes

1

Intubation duration

Time to extubation post surgery measured in hours

Time frame
From end of surgery time to extubation time
2

ICU length of stay

Time spent in ICU post-surgery measured in hours

Time frame
From end of surgery time to ICU discharge time, assessed up to 10 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cardiology Research UBC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: