Minimally Invasive Coronary Revascularization SurgeryITcratsNCT06988735
Impact of Total Coronary Revascularization Via Left Anterior Thoracotomy (TCRAT) vs. Robotic-Assisted Harvesting of LIMA (ITcrats)
A study testing Nonrobotic TCRAT and Robotic TCRAT in people with Minimally Invasive Coronary Revascularization Surgery and Elective Surgery, run by Mohamed R El Tahan at 1 site in Saudi Arabia.
Trial summary
The two types of total coronary revascularization via left anterior thoracotomy (TCRAT) might have their potential benefits and disadvantages. The proposed randomized clinical trial here will compare 'RA-TCRAT' with 'Nonrobotic TCRAT' procedures concerning effects on hospital stays, overall healthcare costs, safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Coronary Revascularization Surgery, Elective Surgery
- What is being tested?
- Nonrobotic TCRAT and Robotic TCRAT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for any type of elective minimally invasive coronary revascularization surgery.
- Using CPB.
- General anesthesia is provided in an endotracheally intubated patient
Who cannot join
- Planned for coronary revascularization surgery without CPB;
- Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
- LVEF less than 35%;
- Preoperative cardiogenic shock;
- Pregnancy;
- Scheduled for re-do or emergency surgery;
Show all 10Show fewer
- Consent for another interventional study during anesthesia;
- No written informed consent;
- Preoperative need for mechanical circulatory support;
- Preoperative need for invasive ventilatory support;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Imam Abdulrahamn Bin Faisal University (Former, Dammam University)
Dammam, Eastern, Saudi Arabia,, 31952
Mohamed R El Tahan, MD, 00966569371849, mohamedrefaateltahan@yahoo.com
Fahad Makhdoum, MD, fmakhdom@gmail.com
About this study
Official title: Impact of Total Coronary Revascularization Via Left Anterior Thoracotomy (TCRAT) vs. Robotic-Assisted Harvesting of Left Internal Thoracic Artery on Hospital Stay (ITcrats)
The two types of total coronary revascularization via left anterior thoracotomy (TCRAT) might have their potential benefits and disadvantages. The proposed randomized clinical trial here will compare 'RA-TCRAT' with 'Nonrobotic TCRAT' procedures concerning effects on hospital stays, overall healthcare costs, safety, and feasibility. If the two TCRAT procedures are comparably effective and safe, the 'Nonrobotic TCRAT' procedure is probably preferred as it seems easier to use. However, if the 'Nonrobotic TCRAT' procedure is less effective and less safe than the "robotic TCRAT,' that procedure should be preferred.
Read the detailed description
Rationale
A recent study involving 1,195 patients from the Society of Thoracic Surgeons Registry undergoing robotic-assisted-minimally-invasive direct coronary artery bypass (RA-MIDCAB) by 114 surgeons between 2014 and 2019 showed that surgeons can quickly reduce complication rates by building up the learning curve. It is yet unclear if robotic-assisted harvesting of the left internal thoracic artery (RA-LITA) would offer a benefit over total coronary revascularization via left anterior thoracotomy (TCRAT) in terms of the postoperative hospital stay and cost of healthcare. That raises the need to examine the impact of RA-LITA compared with TCRAT on these crucial clinical outcomes.
Objective
The primary objective of this prospective randomized clinical trial (RCT) is, compared with TCRAT, to examine the impact of robotic-assisted coronary artery bypass graft (RA-CABG) on the length of hospital stay in diverse patients scheduled for elective surgical coronary revascularization.
Secondary objectives include identifying the overall costs and charges of healthcare, operating room and intensive care unit (ICU) stays, postoperative bleeding, need for re-explorative surgery or transfusion, postoperative major adverse cardiovascular and cerebrovascular events (MACCE)], acute kidney injury (AKI), and surgical related complications and 30-days and 3-months need for hospital re-admission and survival after adult cardiac surgical coronary revascularization using cardiopulmonary bypass (CPB).
Hypothesis
It is hypothesized that RA-total coronary revascularization via left anterior thoracotomy (TCRAT) might have shorter hospital stays than the nonrobotic assisted TCRAT in adult patients undergoing elective coronary revascularization surgery.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness
There is no expected patient burden or risk other than the estimated risks for the coronary revascularization surgery. Patient burden and risks are low, and the two surgical approaches (nonrobotic TCRAT and RA-CABG/TCRAT) are being used widely and interchangeably. The collection of patients' outcome data from hospital charts and (electronic) medical records systems causes no harm to the patients; patients will not experience any discomfort from any of the study interventions because they will be performed during general anesthesia.
INTRODUCTION AND RATIONALE
3.1 TCRAT has a significant impact on outcomes.
The main goals of minimally invasive cardiac surgery (MICS) are to avoid sternotomy, reduce postoperative blood product transfusion, shorten ventilation times, shorten intensive care and hospital stays, improve the quality of postoperative analgesia, and expedite physical recovery.
TECRAT emerged as a promising MICS procedure. TCRAT has been shown to have a likely success rate of 95%, defined as complete revascularization in a cohort of 102 multivessel coronary artery disease (MV-CAD) patients with diverse age, body mass index (BMI), and left-ventricular ejection fraction (LVEF) in conjunction with low incidences of in-hospital mortality, CVA, AMI and need for revascularization in 2%. Muliarterial TCRAT increased the aortic cross-clamping and operating room times without further improving these outcomes or shortening hospital stays.
3.2 Robotic totally endoscopic CABG (TE-CABG)
Robotic TE-CABG is technically more challenging than RA-CABG. Kofer et al. compared the 12 years of single-center experience performing conventional CABG or TE-CABG in a propensity score-matched retrospective study. They identified similar age groups, log European System for Cardiac Operative Risk Evaluation (EuroSCORE), perioperative mortality, AMI, and stroke rate, and long-term survival and freedom from major adverse cardiac and cerebral events at 1, 5, and 10 years after surgery between the two groups. TE-CABG took 40% longer CPB and 67% cross-clamp times. That doubts the superiority of TE-CABG over the RA-MIDCAB or RA-TCRAT.
3.3. RA-MIDCAB
MIDCAB is performed without the use of CPB with associated fewer complications such as perioperative CVA due to avoidance of aortic manipulation. CPB might be required in rare cases during MIDCAB procedures that necessitate peripheral cannulation to avoid a sternotomy, which could be challenging in patients with severe peripheral vascular disease and morbidly obese patients who would benefit the most from avoiding a sternotomy. A RA-MIDCAB procedure may be possible in such patients.
Patrick et al. demonstrated a growing learning curve after the 10th RA-MIDCAB procedure in terms of reduced rates of approach conversion (odds ratio, 0.27; 95% CI, 0.09-0.84) and improved procedural success (odds ratio, 1.96; 95% CI, 1.00-3.84). A cohort of 605 RA-MIDCAB patients performed at a single center over 18 years showed a reduced conversion rate to sternotomy for any cause, from 16.0% of the first 200 cases to 6.9% of the last 405 patients. The mortality rate was 0.3%, the patency rate of the LITA-to-left anterior descending (LAD) coronary artery anastomosis was 97.4%, surgical re-exploration for bleeding in 1.8% of patients, and the transfusion rate was 9.2%.
A previous study found that compared with those who underwent conventional CABG (n=235), patients who received RA-CABG (n=281) had fewer risk factors, lower in-hospital and long-term mortality but had comparable incidences of target lesion revascularization (TLR), target vessel revascularization (TVR), AMI, and stroke. Interestingly, neither the residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score nor completeness of revascularization were related to the long-term mortality.
3.4. RA-CABG: An emerged approach to improve outcomes
A retrospective study demonstrated that compared with MIDCAB, RA-CABG had comparable complete revascularization, one-year graft patency, surgical conversion, mortality rates, more extended operating room stays, and shorter ICU stays. To our knowledge, no RCT compares the impacts of TCRAT and RA-TCRAT CABG on successful revascularization, mortality, and postoperative CVA and AMI.
3.5. Feasibility
The two types of TCRAT (nonrobotic or R.A.) have never been compared in terms of feasibility. 'RA-TCRAT' procedures are more complex to perform and might take longer durations to be accomplished, increasing the overall healthcare costs, which could be unacceptable for both the stakeholders. 'Non-RA-TCRAT' procedures are more straightforward to perform and are thus easier to learn, but most importantly, they take much less time.
- Being tested
- Nonrobotic TCRAT, Robotic TCRAT
- Keywords
- minimally invasive coronary revascularization surgery, robotic-assisted coronary artery bypass graft (RA-CABG), major adverse cardiovascular events (MACCE), major adverse cerebrovascular events, cardiopulmonary bypass (CPB), hospital stays, costs and charges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonrobotic TCRATProcedure or surgery
Nonrobotic TCRAT for CABG
Robotic TCRATProcedure or surgery
Robotic TCRAT for CABG
| Study group | Role | What they receive |
|---|---|---|
| Nonrobotic TCRAT | Placebo comparator | Nonrobotic TCRAT for CABG Receives: Procedure: Nonrobotic TCRAT |
| Robotic TCRAT | Active comparator | Robotic TCRAT for CABG Receives: Procedure: Robotic TCRAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of hospital stay
The primary outcome is the length of hospital stay, defined as the time from surgery until discharge or in-hospital death.
Measured: For 120 days from surgery
Secondary outcomes (22)
Overall costs and charges
The overall healthcare costs and healthcare charges
Measured: For 120 days from surgery until hospital discharge or death
The operating room stay
The operating room stays from entrance to transferring the patient to the ICU.
Measured: For 12 hours from entrance to the operating rooms
The postoperative ICU stay
The postoperative ICU stay from surgery date and time.
Measured: For 120 days from surgery
The need for re-explorative surgery during the same admission.
The need for re-explorative surgery during the same admission.
Measured: For 120 days from surgery
Perioperative need for packed red blood cells (PRBCs) transfusion
Perioperative need for transfusing packed red blood cells (PRBCs) 72 hours from surgery
Measured: For 72 hours from surgery
Perioperative need for fresh frozen plasma (FFP) transfusion
Perioperative need for transfusing fresh frozen plasma (FFP)
Measured: For 72 hours from surgery
Perioperative need for platelets concentrate transfusion
Perioperative need for transfusing platelets concentrate for 72 hours from surgery
Measured: For 72 hours from surgery
Perioperative need for cryoprecipitates transfusion
Perioperative need for transfusing cryoprecipitates transfusion for 72 hours from surgery
Measured: For 72 hours from surgery
Perioperative need for recombinant factor VII administration
Perioperative need for administering recombinant factor VII for 72 hours from surgery
Measured: For 72 hours from surgery
The cumulative postoperative chest tube outputs
The cumulative postoperative chest tube outputs for 48 hours after surgery.
Measured: For 48 hours after surgery.
Any cause of in-hospital death during the same admission
Any cause of in-hospital death during the same admission
Measured: For 120 days from surgery until death or hospital discharge
In-hospital acute myocardial infarction (AMI)
The incidence of in-hospital acute myocardial infarction (AMI) until hospital discharge or in-hospital death.
Measured: For 120 days from surgery until death or hospital discharge
In-hospital acute ischemic stroke
The incidence of in-hospital acute ischemic stroke until hospital discharge or in-hospital death.
Measured: For 120 days from surgery until death or hospital discharge
In-hospital acute kidney injury (AKI)
The incidence of in-hospital acute kidney injury (AKI) until hospital discharge or in-hospital death.
Measured: For 120 days from surgery until death or hospital discharge
Need to intraoperative conversion to sternotomy.
Need to intraoperative conversion from minimally-invasive thoracotomy to open sternotomy.
Measured: For 12 hours from the begining of surgery
Graft's pulsatility index (P.I.).
Post-CPB graft's pulsatility index (P.I.).
Measured: Intraoperatively after discontinuation of the CPB
The need for postoperative coronary revascularization
The need for postoperative surgical or catheter angiographic coronary revascularization
Measured: For 180 days from surgery
In-hospital limb ischemia
The incidence of limb ischemia until hospital discharge or in-hospital death.
Measured: For 120 days from surgery until death or hospital discharge
The need for any-cause hospital re-admission within 30 days after surgery.
The need for any-cause hospital re-admission within 30 days after surgery.
Measured: For 30 days after surgery.
The need for any-cause hospital re-admission within 90 days after surgery.
The need for any-cause hospital re-admission within 90 days after surgery.
Measured: For 90 days after surgery.
All-cause mortality at 30 days after surgery
All-cause mortality at 30 days after surgery
Measured: For 30 days after surgery
All-cause mortality at 90 days after surgery
All-cause mortality at 90 days after surgery
Measured: For 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive Coronary Revascularization SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center prospective randomized controlled clinical trial- and patient-blinded comparative trial in patients scheduled for surgical coronary revascularization. The RCT will be conducted according to Good Clinical Practice (GCP) Guidelines and comply with the principles of the Declaration of Helsinki. The RCT will be registered in a public registry, and the study protocol with its statistical analysis plan will be published before the enrollment of the first patient.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed R El Tahan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed R El Tahan, Imam Abdulrahman Bin Faisal University
- Investigators
- Mohamed R El Tahan, MD, Study chair, Consultant in Cardiac AnesthesiaFahad Makhdoum, MD, Principal investigator, Assistant Professor, Cardiac SurgeryYasser F ElGhoneimy, MD, Study director, Professor, Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988735
- Sponsor's protocol ID
- IABF-16-05-25
- Acronym
- ITcrats
- Status last verified
- Jun 2025
- First submitted
- 16 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study database will be locked upon completion of data entry and resolution of all discrepancies or missing data, or when the investigators determine that no further resolution is feasible despite reasonable efforts. Prior to locking, a final review of the database will be conducted. Once locked, the dataset will be exported for statistical analysis. De-identified individual participant data (IPD), the study protocol, and statistical analysis plan will be made available upon reasonable request from qualified researchers beginning six months after publication and for a period of five years. Data access will be granted following review and approval of a research proposal and the signing of a data access agreement. Requests should be directed to the corresponding author.
Publications
Gong W, Cai J, Wang Z, Chen A, Ye X, Li H, Zhao Q. Robot-assisted coronary artery bypass grafting improves short-term outcomes compared with minimally invasive direct coronary artery bypass grafting. J Thorac Dis. 2016 Mar;8(3):459-68. doi: 10.21037/jtd.2016.02.67.
PubMed 27076941Lin TH, Wang CW, Shen CH, Chang KH, Lai CH, Liu TJ, Chen KJ, Chen YW, Lee WL, Su CS. Clinical outcomes of multivessel coronary artery disease patients revascularized by robot-assisted vs conventional standard coronary artery bypass graft surgeries in real-world practice. Medicine (Baltimore). 2021 Jan 22;100(3):e23830. doi: 10.1097/MD.0000000000023830.
PubMed 33545949Giambruno V, Chu MW, Fox S, Swinamer SA, Rayman R, Markova Z, Barnfield R, Cooper M, Boyd DW, Menkis A, Kiaii B. Robotic-assisted coronary artery bypass surgery: an 18-year single-centre experience. Int J Med Robot. 2018 Jun;14(3):e1891. doi: 10.1002/rcs.1891. Epub 2018 Jan 19.
PubMed 29349908Marin-Cuartas M, Sa MP, Torregrossa G, Davierwala PM. Minimally invasive coronary artery surgery: Robotic and nonrobotic minimally invasive direct coronary artery bypass techniques. JTCVS Tech. 2021 Oct 13;10:170-177. doi: 10.1016/j.xjtc.2021.10.008. eCollection 2021 Dec. No abstract available.
PubMed 34984377Kofler M, Stastny L, Reinstadler SJ, Dumfarth J, Kilo J, Friedrich G, Schachner T, Grimm M, Bonatti J, Bonaros N. Robotic Versus Conventional Coronary Artery Bypass Grafting: Direct Comparison of Long-Term Clinical Outcome. Innovations (Phila). 2017 Jul/Aug;12(4):239-246. doi: 10.1097/IMI.0000000000000393.
PubMed 28777131Babliak O, Demianenko V, Melnyk Y, Revenko K, Babliak D, Stohov O, Pidgayna L. Multivessel Arterial Revascularization via Left Anterior Thoracotomy. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):655-662. doi: 10.1053/j.semtcvs.2020.02.032. Epub 2020 Feb 28.
PubMed 32114114Sellin C, Asch S, Belmenai A, Mourad F, Voss M, Dorge H. Early Results of Total Coronary Revascularization via Left Anterior Thoracotomy. Thorac Cardiovasc Surg. 2023 Sep;71(6):448-454. doi: 10.1055/s-0042-1758149. Epub 2022 Nov 11.
PubMed 36368676Babliak O, Demianenko V, Melnyk Y, Revenko K, Pidgayna L, Stohov O. Complete Coronary Revascularization via Left Anterior Thoracotomy. Innovations (Phila). 2019 Aug;14(4):330-341. doi: 10.1177/1556984519849126. Epub 2019 May 20.
PubMed 31106625Caynak B, Sicim H. Routine minimally invasive approach via left anterior mini-thoracotomy in multivessel coronary revascularization. J Card Surg. 2022 Apr;37(4):769-776. doi: 10.1111/jocs.16259. Epub 2022 Jan 20.
PubMed 35060197Marin Cuartas M, Javadikasgari H, Pfannmueller B, Seeburger J, Gillinov AM, Suri RM, Borger MA. Mitral valve repair: Robotic and other minimally invasive approaches. Prog Cardiovasc Dis. 2017 Nov-Dec;60(3):394-404. doi: 10.1016/j.pcad.2017.11.002. Epub 2017 Nov 9.
PubMed 29128572Smilowitz NR, Gupta N, Ramakrishna H, Guo Y, Berger JS, Bangalore S. Perioperative Major Adverse Cardiovascular and Cerebrovascular Events Associated With Noncardiac Surgery. JAMA Cardiol. 2017 Feb 1;2(2):181-187. doi: 10.1001/jamacardio.2016.4792.
PubMed 28030663Patrick WL, Iyengar A, Han JJ, Mays JC, Helmers M, Kelly JJ, Wang X, Ghoreishi M, Taylor BS, Atluri P, Desai ND, Williams ML. The learning curve of robotic coronary arterial bypass surgery: A report from the STS database. J Card Surg. 2021 Nov;36(11):4178-4186. doi: 10.1111/jocs.15945. Epub 2021 Aug 29.
PubMed 34459029
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Total Coronary Revascularization Via Left Anterior Thoracotomy (TCRAT) vs. Robotic-Assisted Harvesting of Left Internal Thoracic Artery on Hospital Stay (ITcrats)
- ClinicalTrials.gov ID
- NCT06988735
- Acronym / sponsor ID
- ITcrats / IABF-16-05-25
- Keywords
- minimally invasive coronary revascularization surgery, robotic-assisted coronary artery bypass graft (RA-CABG), major adverse cardiovascular events (MACCE), major adverse cerebrovascular events, cardiopulmonary bypass (CPB), hospital stays, costs and charges
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Mohamed R El TahanUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The two types of total coronary revascularization via left anterior thoracotomy (TCRAT) might have their potential benefits and disadvantages. The proposed randomized clinical trial here will compare 'RA-TCRAT' with 'Nonrobotic TCRAT' procedures concerning effects on hospital stays, overall healthcare costs, safety, and feasibility. If the two TCRAT procedures are comparably effective and safe, the 'Nonrobotic TCRAT' procedure is probably preferred as it seems easier to use. However, if the 'Nonrobotic TCRAT' procedure is less effective and less safe than the "robotic TCRAT,' that procedure should be preferred.
Detailed description
Rationale
A recent study involving 1,195 patients from the Society of Thoracic Surgeons Registry undergoing robotic-assisted-minimally-invasive direct coronary artery bypass (RA-MIDCAB) by 114 surgeons between 2014 and 2019 showed that surgeons can quickly reduce complication rates by building up the learning curve. It is yet unclear if robotic-assisted harvesting of the left internal thoracic artery (RA-LITA) would offer a benefit over total coronary revascularization via left anterior thoracotomy (TCRAT) in terms of the postoperative hospital stay and cost of healthcare. That raises the need to examine the impact of RA-LITA compared with TCRAT on these crucial clinical outcomes.
Objective
The primary objective of this prospective randomized clinical trial (RCT) is, compared with TCRAT, to examine the impact of robotic-assisted coronary artery bypass graft (RA-CABG) on the length of hospital stay in diverse patients scheduled for elective surgical coronary revascularization.
Secondary objectives include identifying the overall costs and charges of healthcare, operating room and intensive care unit (ICU) stays, postoperative bleeding, need for re-explorative surgery or transfusion, postoperative major adverse cardiovascular and cerebrovascular events (MACCE)], acute kidney injury (AKI), and surgical related complications and 30-days and 3-months need for hospital re-admission and survival after adult cardiac surgical coronary revascularization using cardiopulmonary bypass (CPB).
Hypothesis
It is hypothesized that RA-total coronary revascularization via left anterior thoracotomy (TCRAT) might have shorter hospital stays than the nonrobotic assisted TCRAT in adult patients undergoing elective coronary revascularization surgery.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness
There is no expected patient burden or risk other than the estimated risks for the coronary revascularization surgery. Patient burden and risks are low, and the two surgical approaches (nonrobotic TCRAT and RA-CABG/TCRAT) are being used widely and interchangeably. The collection of patients' outcome data from hospital charts and (electronic) medical records systems causes no harm to the patients; patients will not experience any discomfort from any of the study interventions because they will be performed during general anesthesia.
INTRODUCTION AND RATIONALE
3.1 TCRAT has a significant impact on outcomes.
The main goals of minimally invasive cardiac surgery (MICS) are to avoid sternotomy, reduce postoperative blood product transfusion, shorten ventilation times, shorten intensive care and hospital stays, improve the quality of postoperative analgesia, and expedite physical recovery.
TECRAT emerged as a promising MICS procedure. TCRAT has been shown to have a likely success rate of 95%, defined as complete revascularization in a cohort of 102 multivessel coronary artery disease (MV-CAD) patients with diverse age, body mass index (BMI), and left-ventricular ejection fraction (LVEF) in conjunction with low incidences of in-hospital mortality, CVA, AMI and need for revascularization in 2%. Muliarterial TCRAT increased the aortic cross-clamping and operating room times without further improving these outcomes or shortening hospital stays.
3.2 Robotic totally endoscopic CABG (TE-CABG)
Robotic TE-CABG is technically more challenging than RA-CABG. Kofer et al. compared the 12 years of single-center experience performing conventional CABG or TE-CABG in a propensity score-matched retrospective study. They identified similar age groups, log European System for Cardiac Operative Risk Evaluation (EuroSCORE), perioperative mortality, AMI, and stroke rate, and long-term survival and freedom from major adverse cardiac and cerebral events at 1, 5, and 10 years after surgery between the two groups. TE-CABG took 40% longer CPB and 67% cross-clamp times. That doubts the superiority of TE-CABG over the RA-MIDCAB or RA-TCRAT.
3.3. RA-MIDCAB
MIDCAB is performed without the use of CPB with associated fewer complications such as perioperative CVA due to avoidance of aortic manipulation. CPB might be required in rare cases during MIDCAB procedures that necessitate peripheral cannulation to avoid a sternotomy, which could be challenging in patients with severe peripheral vascular disease and morbidly obese patients who would benefit the most from avoiding a sternotomy. A RA-MIDCAB procedure may be possible in such patients.
Patrick et al. demonstrated a growing learning curve after the 10th RA-MIDCAB procedure in terms of reduced rates of approach conversion (odds ratio, 0.27; 95% CI, 0.09-0.84) and improved procedural success (odds ratio, 1.96; 95% CI, 1.00-3.84). A cohort of 605 RA-MIDCAB patients performed at a single center over 18 years showed a reduced conversion rate to sternotomy for any cause, from 16.0% of the first 200 cases to 6.9% of the last 405 patients. The mortality rate was 0.3%, the patency rate of the LITA-to-left anterior descending (LAD) coronary artery anastomosis was 97.4%, surgical re-exploration for bleeding in 1.8% of patients, and the transfusion rate was 9.2%.
A previous study found that compared with those who underwent conventional CABG (n=235), patients who received RA-CABG (n=281) had fewer risk factors, lower in-hospital and long-term mortality but had comparable incidences of target lesion revascularization (TLR), target vessel revascularization (TVR), AMI, and stroke. Interestingly, neither the residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score nor completeness of revascularization were related to the long-term mortality.
3.4. RA-CABG: An emerged approach to improve outcomes
A retrospective study demonstrated that compared with MIDCAB, RA-CABG had comparable complete revascularization, one-year graft patency, surgical conversion, mortality rates, more extended operating room stays, and shorter ICU stays. To our knowledge, no RCT compares the impacts of TCRAT and RA-TCRAT CABG on successful revascularization, mortality, and postoperative CVA and AMI.
3.5. Feasibility
The two types of TCRAT (nonrobotic or R.A.) have never been compared in terms of feasibility. 'RA-TCRAT' procedures are more complex to perform and might take longer durations to be accomplished, increasing the overall healthcare costs, which could be unacceptable for both the stakeholders. 'Non-RA-TCRAT' procedures are more straightforward to perform and are thus easier to learn, but most importantly, they take much less time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-center prospective randomized controlled clinical trial- and patient-blinded comparative trial in patients scheduled for surgical coronary revascularization. The RCT will be conducted according to Good Clinical Practice (GCP) Guidelines and comply with the principles of the Declaration of Helsinki. The RCT will be registered in a public registry, and the study protocol with its statistical analysis plan will be published before the enrollment of the first patient.
| Arm | Type | Receives |
|---|---|---|
| Nonrobotic TCRAT | Placebo comparator | Procedure: Nonrobotic TCRATNonrobotic TCRAT for CABG |
| Robotic TCRAT | Active comparator | Procedure: Robotic TCRATRobotic TCRAT for CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for any type of elective minimally invasive coronary revascularization surgery.
- Using CPB.
- General anesthesia is provided in an endotracheally intubated patient
Key exclusion criteria (10 listed)
- Planned for coronary revascularization surgery without CPB;
- Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
- LVEF less than 35%;
- Preoperative cardiogenic shock;
- Pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonrobotic TCRATNonrobotic TCRAT for CABG | Procedure or surgery | Nonrobotic TCRAT |
| Robotic TCRATRobotic TCRAT for CABG | Procedure or surgery | Robotic TCRAT |
Primary outcome
The length of hospital stay
Time frame: For 120 days from surgery
The primary outcome is the length of hospital stay, defined as the time from surgery until discharge or in-hospital death.
22 secondary outcomes
Overall costs and charges
Time frame: For 120 days from surgery until hospital discharge or death
The operating room stay
Time frame: For 12 hours from entrance to the operating rooms
The postoperative ICU stay
Time frame: For 120 days from surgery
The need for re-explorative surgery during the same admission.
Time frame: For 120 days from surgery
Perioperative need for packed red blood cells (PRBCs) transfusion
Time frame: For 72 hours from surgery
Perioperative need for fresh frozen plasma (FFP) transfusion
Time frame: For 72 hours from surgery
Perioperative need for platelets concentrate transfusion
Time frame: For 72 hours from surgery
Perioperative need for cryoprecipitates transfusion
Time frame: For 72 hours from surgery
Perioperative need for recombinant factor VII administration
Time frame: For 72 hours from surgery
The cumulative postoperative chest tube outputs
Time frame: For 48 hours after surgery.
Any cause of in-hospital death during the same admission
Time frame: For 120 days from surgery until death or hospital discharge
In-hospital acute myocardial infarction (AMI)
Time frame: For 120 days from surgery until death or hospital discharge
In-hospital acute ischemic stroke
Time frame: For 120 days from surgery until death or hospital discharge
In-hospital acute kidney injury (AKI)
Time frame: For 120 days from surgery until death or hospital discharge
Need to intraoperative conversion to sternotomy.
Time frame: For 12 hours from the begining of surgery
Graft's pulsatility index (P.I.).
Time frame: Intraoperatively after discontinuation of the CPB
The need for postoperative coronary revascularization
Time frame: For 180 days from surgery
In-hospital limb ischemia
Time frame: For 120 days from surgery until death or hospital discharge
The need for any-cause hospital re-admission within 30 days after surgery.
Time frame: For 30 days after surgery.
The need for any-cause hospital re-admission within 90 days after surgery.
Time frame: For 90 days after surgery.
All-cause mortality at 30 days after surgery
Time frame: For 30 days after surgery
All-cause mortality at 90 days after surgery
Time frame: For 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Results publication: PubMed 27076941Gong W, Cai J, Wang Z, Chen A, Ye X, Li H, Zhao Q. Robot-assisted coronary artery bypass grafting improves short-term outcomes compared with minimally invasive direct coronary artery bypass grafting. J Thorac Dis. 2016 Mar;8(3):459-68. doi: 10.21037/jtd.2016.02.67.
- Results publication: PubMed 33545949Lin TH, Wang CW, Shen CH, Chang KH, Lai CH, Liu TJ, Chen KJ, Chen YW, Lee WL, Su CS. Clinical outcomes of multivessel coronary artery disease patients revascularized by robot-assisted vs conventional standard coronary artery bypass graft surgeries in real-world practice. Medicine (Baltimore). 2021 Jan 22;100(3):e23830. doi: 10.1097/MD.0000000000023830.
- Results publication: PubMed 29349908Giambruno V, Chu MW, Fox S, Swinamer SA, Rayman R, Markova Z, Barnfield R, Cooper M, Boyd DW, Menkis A, Kiaii B. Robotic-assisted coronary artery bypass surgery: an 18-year single-centre experience. Int J Med Robot. 2018 Jun;14(3):e1891. doi: 10.1002/rcs.1891. Epub 2018 Jan 19.
- Results publication: PubMed 34984377Marin-Cuartas M, Sa MP, Torregrossa G, Davierwala PM. Minimally invasive coronary artery surgery: Robotic and nonrobotic minimally invasive direct coronary artery bypass techniques. JTCVS Tech. 2021 Oct 13;10:170-177. doi: 10.1016/j.xjtc.2021.10.008. eCollection 2021 Dec. No abstract available.
- Results publication: PubMed 28777131Kofler M, Stastny L, Reinstadler SJ, Dumfarth J, Kilo J, Friedrich G, Schachner T, Grimm M, Bonatti J, Bonaros N. Robotic Versus Conventional Coronary Artery Bypass Grafting: Direct Comparison of Long-Term Clinical Outcome. Innovations (Phila). 2017 Jul/Aug;12(4):239-246. doi: 10.1097/IMI.0000000000000393.
- Results publication: PubMed 32114114Babliak O, Demianenko V, Melnyk Y, Revenko K, Babliak D, Stohov O, Pidgayna L. Multivessel Arterial Revascularization via Left Anterior Thoracotomy. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):655-662. doi: 10.1053/j.semtcvs.2020.02.032. Epub 2020 Feb 28.
- Results publication: PubMed 36368676Sellin C, Asch S, Belmenai A, Mourad F, Voss M, Dorge H. Early Results of Total Coronary Revascularization via Left Anterior Thoracotomy. Thorac Cardiovasc Surg. 2023 Sep;71(6):448-454. doi: 10.1055/s-0042-1758149. Epub 2022 Nov 11.
- Results publication: PubMed 31106625Babliak O, Demianenko V, Melnyk Y, Revenko K, Pidgayna L, Stohov O. Complete Coronary Revascularization via Left Anterior Thoracotomy. Innovations (Phila). 2019 Aug;14(4):330-341. doi: 10.1177/1556984519849126. Epub 2019 May 20.
- Results publication: PubMed 35060197Caynak B, Sicim H. Routine minimally invasive approach via left anterior mini-thoracotomy in multivessel coronary revascularization. J Card Surg. 2022 Apr;37(4):769-776. doi: 10.1111/jocs.16259. Epub 2022 Jan 20.
- Results publication: PubMed 29128572Marin Cuartas M, Javadikasgari H, Pfannmueller B, Seeburger J, Gillinov AM, Suri RM, Borger MA. Mitral valve repair: Robotic and other minimally invasive approaches. Prog Cardiovasc Dis. 2017 Nov-Dec;60(3):394-404. doi: 10.1016/j.pcad.2017.11.002. Epub 2017 Nov 9.
- Results publication: PubMed 28030663Smilowitz NR, Gupta N, Ramakrishna H, Guo Y, Berger JS, Bangalore S. Perioperative Major Adverse Cardiovascular and Cerebrovascular Events Associated With Noncardiac Surgery. JAMA Cardiol. 2017 Feb 1;2(2):181-187. doi: 10.1001/jamacardio.2016.4792.
- Results publication: PubMed 34459029Patrick WL, Iyengar A, Han JJ, Mays JC, Helmers M, Kelly JJ, Wang X, Ghoreishi M, Taylor BS, Atluri P, Desai ND, Williams ML. The learning curve of robotic coronary arterial bypass surgery: A report from the STS database. J Card Surg. 2021 Nov;36(11):4178-4186. doi: 10.1111/jocs.15945. Epub 2021 Aug 29.
- Individual participant dataSharing planned: Yes. The study database will be locked upon completion of data entry and resolution of all discrepancies or missing data, or when the investigators determine that no further resolution is feasible despite reasonable efforts. Prior to locking, a final review of the database will be conducted. Once locked, the dataset will be exported for statistical analysis. De-identified individual participant data (IPD), the study protocol, and statistical analysis plan will be made available upon reasonable request from qualified researchers beginning six months after publication and for a period of five years. Data access will be granted following review and approval of a research proposal and the signing of a data access agreement. Requests should be directed to the corresponding author.
Related trials for Minimally Invasive Coronary Revascularization Surgery
Recruiting
Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting
Coronary Artery Disease (CAD), Bypass, Cardiopulmonary
RecruitingObservational study
Minimally Invasive Coronary Artery Bypass Supported by Cangrelor
Coronary Artery Disease, Antiplatelet Therapy
Not yet recruiting
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery
Coronary Artery Disease, Multivessel Coronary Artery Disease
Not yet recruiting
Complete Revascularization Via Inferior Part-sternotomy
Complete Revascularization, Coronary Artery Bypass Grafting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed R El Tahan, MD study chair
Consultant in Cardiac Anesthesia
Fahad Makhdoum, MD principal investigator
Assistant Professor, Cardiac Surgery
Yasser F ElGhoneimy, MD study director
Professor, Cardiac Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonrobotic TCRAT and Robotic TCRAT in people with Minimally Invasive Coronary Revascularization Surgery and Elective Surgery, run by Mohamed R El Tahan at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moahmed R El Tahan, MD (0096569371849, mohamedrefaateltahan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of hospital stay (time frame: For 120 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988735, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.