NCT06378775Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 12 Mar 2024
- Start date
- 1 May 2024
- Primary completion date
- 1 May 2027
- Lead sponsor
- Cardiology Research UBC
- Diseases
- Coronary artery disease
- NCT number
- NCT06378775
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 May 2024 to the primary completion date, 1 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring emergent surgery, including patients with hemodynamic instability,
Other illness
- Significant left main coronary artery disease,
Lab values
- Ejection fraction \< 30%,
- Patients with GFR \< 30,
- Patients unable to take dual anti-platelet agents due to high bleeding risk,
Other
- Patients with anatomy not suitable for a robotically-assisted approach (by CT chest).
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.