Complete RevascularizationNCT05835167
Complete Revascularization Via Inferior Part-sternotomy
A study testing Inferior part-sternotomy and Full median sternotomy in people with Complete Revascularization and Coronary Artery Bypass Grafting, run by China National Center for Cardiovascular Diseases.
Trial summary
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy, We aim to randomize 260 patients undergoing isolated Coronary artery bypass grafting (CABG) to compare the ratios of complete… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complete Revascularization, Coronary Artery Bypass Grafting, Multivessel Coronary Artery Disease
- What is being tested?
- Inferior part-sternotomy and Full median sternotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2023to 4 May 2035
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo primary isolated open-chest CABG with multi-vessel coronary disease(left main artery disease with right coronary artery disease,or three-vessel disease)
Who cannot join
- Single vessel disease, double vessel disease, left main artery disease without right coronary artery disease.
- Concomitant cardiac surgeries(i.e. valve repair or replacement, Maze surgery, left ventricular repair due to ventricular aneurysm).
- Redo CABG.
- Emergent CABG.
- Left ventricular ejection fraction(EF≤35%).
- Severe atherosclerosis of the ascending aorta.
Show all 11Show fewer
- Subjects tend to choose surgical approach (via full median sternotomy/inferior part-sternotomy) .
- Malignant tumor or other severe systemic diseases.
- Severe renal insufficiency (i.e. creatinine >200 μmol/L).
- Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer.
- Participant of other ongoing clinical trials.
About this study
Official title: Minimally Invasive Coronary Artery Bypass Grafting Achieving Complete Revascularization of Multivessel Coronary Artery Disease Via Inferior Part-Sternotomy (The ACRIS-MICABG Trial)
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy, We aim to randomize 260 patients undergoing isolated Coronary artery bypass grafting (CABG) to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China.
Read the detailed description
Coronary artery bypass grafting (CABG) has always been the gold standard for surgical treatment of coronary artery disease (CAD), especially for left main (LM) coronary disease, patients with high SYNTAX scores, and diabetes mellitus. By minimally invasive strategy, patients recover significantly faster in the early post-operative period. However, a prospective randomized controlled trials is needed to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG.
Objectives:
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy.
Study design:
This is a prospective, multicenter, open-label, randomized controlled trial. We aim to randomize 260 patients undergoing isolated CABG to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China. We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. Patients who give informed consent are randomly assigned to undergo inferior part-sternotomy CABG or full median sternotomy CABG by a central randomization system. An expert group composed of three doctors with CABG qualifications will develop a plan achieving complete revascularization by coronary angiography images before the operation, including the number and location of proximal and distal anastomoses. The actual bypass procedure will be recorded and compared with the preoperative plan. We will follow-up participants until 10 years after the operation. To reduce the variation among surgeons, we require that all CABG are performed by qualified surgeons. The surgeons in this study needs to have experience in at least 100 cases of full median sternotomy CABG, and at least 5 cases of inferior part-sternotomy CABG.The ethics committees at all 9 participating hospitals approved this study.
Randomization A web-based central randomization system incorporated in the registration system is used for allocation (http://ccsr.cvs-china.com/). The randomization code with fixed block size is generated by SAS. Randomization is stratified by investigation center. When an eligible patient gives informed consent, the investigator logs in to the randomization webpage and obtain the random number along with treatment group (Inferior part-sternotomy or Full median sternotomy group) automatically distributed by the system after the basic patient information be confirmed. The statistician responsible for the randomization code and the staff who develops the Interactive Web-based Response (IWR) system are independent of each other.
Intervention Surgical procedure.The patient is placed in the supine position. Standard intubation and hemodynamic monitoring are used. Heparinization is standardized for on-pump CABG. The surgeon is given discretion to ensure that his choice in surgery would ensure the patient´s safety (including which graft to use or the choice of anatomic regions to revascularize). The surgeries are performed with the usual methods of cardiopulmonary bypass (CPB) with aortic cross-clamp technique. Myocardial protection strategies include blood cardioplegia and moderate hypothermia. For both types of surgeries, an excellent exposure is required.
Inferior part-sternotomy CABG.A sternal saw is used to split the sternum from the xiphoid process to the second intercostal space where the sternum is partially transected by turning the saw rightward. Remaining coronary bypassing techniques are same in both groups according to clinical practice and preference of the operator.
Full median sternotomy CABG. A midline skin incision is made over the sternum, starting from the sternal angle and extending slightly beyond the xiphoid process. The sternum is fully split by a sternal saw.
Medication. All participants are prescribed dual antiplatelet therapy with aspirin 100 mg plus clopidogrel 75 mg daily from the first day post-CABG until 3 months post-operation. Prescription of other concomitant medications such as β-blockers, statins, and antihypertensive agents is determined by local surgeons according to ACC/AHA guidelines.
The trial data will be analyzed on an intention-to-treat basis with patients included in the groups assigned at randomization, irrespective of future management and events.Demographic and clinical variables will be summarized as means (SDs) for continuous and counts (percentages) for categorical variables. Comparisons across the groups will be performed using a 2-tailed unpaired t test for continuous variables and the Pearson's χ2 test for categorical variables. A P value of less than 0.05 will be considered as statistically significant for all analyses.
Clinical events committee. All clinical events including myocardial infarction, stroke, target lesion revascularization, and death will undergo central adjudication by an independent clinical events committee (CEC).
- Conditions
- Complete Revascularization, Coronary Artery Bypass Grafting, Multivessel Coronary Artery Disease
- Being tested
- Inferior part-sternotomy, Full median sternotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior part-sternotomyProcedure or surgery
A midline skin incision of 8 to 10cm in length is made over the sternum, starting from 2-3cm below the sternal angle inferiorly and extending slightly beyond the xiphoid process. A sternal saw is used to split the sternum from the xiphoid process to the second intercostal space where the sternum is partially transected by turning the saw rightward.
Full median sternotomyProcedure or surgery
A midline skin incision is made over the sternum, starting from the sternal angle and extending slightly beyond the xiphoid process. The sternum is fully split by a sternal saw.
| Study group | Role | What they receive |
|---|---|---|
| Inferior part-sternotomy CABG | Experimental | A midline skin incision of 8 to 10cm in length is made over the sternum, starting from 2-3cm below the sternal angle inferiorly and extending slightly beyond the xiphoid process. A sternal saw is used to split the sternum from the xiphoid process to the second intercostal space where the sternum is partially transected by turning the saw rightward. Left internal mammary artery (LIMA)-left anterior descending branch bypass is the first choice for all patients. Remaining coronary bypassing techniques are according to clinical practice and preference of the operator. If it is difficult to perform CABG via inferior part-sternotomy, the treatment strategy convert to full median sternotomy, which is deemed to be failed to achieve complete revascularization via inferior part-sternotomy. Receives: Procedure: Inferior part-sternotomy |
| Full median sternotomy CABG | Active comparator | A midline skin incision is made over the sternum, starting from the sternal angle and extending slightly beyond the xiphoid process. The sternum is fully split by a sternal saw. Remaining coronary bypassing techniques are same in both groups according to clinical practice and preference of the operator. Receives: Procedure: Full median sternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete revascularization rate immediately after surgery
Most surgical groups have adopted the functional definition in their studies. We therefore elected to use a functional definition for complete revascularization in the present study. The coronary vascular tree was divided into 3 separate territories: the left anterior descending artery (LAD), the circumflex artery, and the right coronary artery (RCA).Functional completeness of revascularization is defined as all viable myocardial territories are reperfused, as at least one bypass graft for every diseased primary arterial territory
Measured: Immediately after surgery
Secondary outcomes (7)
The harvest time of left Internal mammary artery (LIMA)
It is defined as the time from skin incision to clamping of the distal part of the LIMA.
Measured: During surgery
Aortic cross-clamp time
Measured: During surgery
Overall operation time
It is defined as the time from skin incision to skin sutured.
Measured: During surgery
Intraoperative real-time blood flow at each anastomosis
It was evaluated intraoperatively using ultrasound flow measurements.
Measured: During surgery
The total amount of postoperative chest tube drainage
This includes the amount of fluid of closed thoracic drainage or thoracentesis drainage due to pleural effusion during hospitalization.
Measured: Up to 4 weeks
The graft patency rate by CTA at 5-7 days, 1 year, 3 years, 5 years, and 10 years after surgery
Graft occlusion is detected by computed tomography angiography (CTA). Grafts are graded into three levels: A (excellent), B (fair), or C (occluded). Contrast filling of the grafts, anastomoses, and coronary arteries beyond the graft are considered in each assessment. Grade A indicates that the graft is patent with ≤50% stenosis. Grade B indicates that graft stenosis is >50% but not occluded. When a graft does not fill with contrast at all, it is considered Grade C and included with string sign found in any segment (including proximal and distal anastomotic site, and main trunk). Both of these findings are considered together and referred to as occlusion in the analysis.The patency rate of grafts = number of grafts in grades A and B/total number of bypass grafts.
Measured: 1week after the surgery；10 years after surgery
The rate of major adverse cardiac or cerebrovascular events (MACCE) at 5-7 days, 1 year, 3 years, 5 years, and 10 years after surgery
MACCE: cardiac death, myocardial infarction, stroke, repeat revascularization and hospitalization for heart failure.
Myocardial infarction (troponin values >10 times the 99th percentile of upper reference limit in association with new Q waves).
Measured: 1week after the surgery；10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start5 May 2023 (estimated)
- Primary completion4 May 2025 (estimated)
- Study completion4 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Complete RevascularizationStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Collaborators
- Tangshan Central Hospital, Baotou Central Hospital, Xiamen Second Hospital, Beijing Shijitan Hospital, Capital Medical University, Peking University International Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, Fuwai Yunnan Cardiovascular Hospital, Henan Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835167
- Sponsor's protocol ID
- 2022-GSP-GG-23
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
PubMed 30165437Lapierre H, Chan V, Sohmer B, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting via a small thoracotomy versus off-pump: a case-matched study. Eur J Cardiothorac Surg. 2011 Oct;40(4):804-10. doi: 10.1016/j.ejcts.2011.01.066. Epub 2011 Mar 9.
PubMed 21393011Ong AT, Serruys PW. Complete revascularization: coronary artery bypass graft surgery versus percutaneous coronary intervention. Circulation. 2006 Jul 18;114(3):249-55. doi: 10.1161/CIRCULATIONAHA.106.614420. No abstract available.
PubMed 16847164Veiga Oliveira P, Madeira M, Ranchordas S, Marques M, Almeida M, Sousa-Uva M, Abecasis M, Neves JP. Complete surgical revascularization: Different definitions, same impact? J Card Surg. 2021 Dec;36(12):4497-4502. doi: 10.1111/jocs.15986. Epub 2021 Sep 16.
PubMed 34533240Sohn SH, Kang Y, Kim JS, Paeng JC, Hwang HY. Impact of Functional vs Anatomic Complete Revascularization in Coronary Artery Bypass Grafting. Ann Thorac Surg. 2023 Apr;115(4):905-912. doi: 10.1016/j.athoracsur.2022.10.029. Epub 2022 Nov 9.
PubMed 36334649Sun HS, Ma WG, Xu JP, Sun LZ, Lu F, Zhu XD. Minimal access heart surgery via lower ministernotomy: experience in 460 cases. Asian Cardiovasc Thorac Ann. 2006 Apr;14(2):109-13. doi: 10.1177/021849230601400206.
PubMed 16551816Kleisli T, Cheng W, Jacobs MJ, Mirocha J, Derobertis MA, Kass RM, Blanche C, Fontana GP, Raissi SS, Magliato KE, Trento A. In the current era, complete revascularization improves survival after coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2005 Jun;129(6):1283-91. doi: 10.1016/j.jtcvs.2004.12.034.
PubMed 15942568Ju F, Li B, Wu H, Sun H. Achieving completed revascularization via inferior mini-sternotomy versus conventional median sternotomy for CABG in patients with multivessel CAD (the ACRIS-MICABG trial): Rationale and design of a multicentre, randomized controlled trial. Contemp Clin Trials. 2026 Aug;167:108362. doi: 10.1016/j.cct.2026.108362. Epub 2026 Jun 11.
PubMed 42276410
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Coronary Artery Bypass Grafting Achieving Complete Revascularization of Multivessel Coronary Artery Disease Via Inferior Part-Sternotomy (The ACRIS-MICABG Trial)
- ClinicalTrials.gov ID
- NCT05835167
- Acronym / sponsor ID
- 2022-GSP-GG-23
- Conditions
- Complete Revascularization, Coronary Artery Bypass Grafting, Multivessel Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Tangshan Central Hospital, Baotou Central Hospital, Xiamen Second Hospital, Beijing Shijitan Hospital, Capital Medical University, Peking University International Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, Fuwai Yunnan Cardiovascular Hospital, Henan Provincial People's Hospital
- Study start
- 5 May 2023 (estimated)
- Primary completion
- 4 May 2025 (estimated)
- Study completion
- 4 May 2035 (estimated)
- First posted
- 28 Apr 2023 (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.
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy, We aim to randomize 260 patients undergoing isolated Coronary artery bypass grafting (CABG) to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China.
Detailed description
Coronary artery bypass grafting (CABG) has always been the gold standard for surgical treatment of coronary artery disease (CAD), especially for left main (LM) coronary disease, patients with high SYNTAX scores, and diabetes mellitus. By minimally invasive strategy, patients recover significantly faster in the early post-operative period. However, a prospective randomized controlled trials is needed to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG.
Objectives:
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy.
Study design:
This is a prospective, multicenter, open-label, randomized controlled trial. We aim to randomize 260 patients undergoing isolated CABG to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China. We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. Patients who give informed consent are randomly assigned to undergo inferior part-sternotomy CABG or full median sternotomy CABG by a central randomization system. An expert group composed of three doctors with CABG qualifications will develop a plan achieving complete revascularization by coronary angiography images before the operation, including the number and location of proximal and distal anastomoses. The actual bypass procedure will be recorded and compared with the preoperative plan. We will follow-up participants until 10 years after the operation. To reduce the variation among surgeons, we require that all CABG are performed by qualified surgeons. The surgeons in this study needs to have experience in at least 100 cases of full median sternotomy CABG, and at least 5 cases of inferior part-sternotomy CABG.The ethics committees at all 9 participating hospitals approved this study.
Randomization A web-based central randomization system incorporated in the registration system is used for allocation (http://ccsr.cvs-china.com/). The randomization code with fixed block size is generated by SAS. Randomization is stratified by investigation center. When an eligible patient gives informed consent, the investigator logs in to the randomization webpage and obtain the random number along with treatment group (Inferior part-sternotomy or Full median sternotomy group) automatically distributed by the system after the basic patient information be confirmed. The statistician responsible for the randomization code and the staff who develops the Interactive Web-based Response (IWR) system are independent of each other.
Intervention Surgical procedure.The patient is placed in the supine position. Standard intubation and hemodynamic monitoring are used. Heparinization is standardized for on-pump CABG. The surgeon is given discretion to ensure that his choice in surgery would ensure the patient´s safety (including which graft to use or the choice of anatomic regions to revascularize). The surgeries are performed with the usual methods of cardiopulmonary bypass (CPB) with aortic cross-clamp technique. Myocardial protection strategies include blood cardioplegia and moderate hypothermia. For both types of surgeries, an excellent exposure is required.
Inferior part-sternotomy CABG.A sternal saw is used to split the sternum from the xiphoid process to the second intercostal space where the sternum is partially transected by turning the saw rightward. Remaining coronary bypassing techniques are same in both groups according to clinical practice and preference of the operator.
Full median sternotomy CABG. A midline skin incision is made over the sternum, starting from the sternal angle and extending slightly beyond the xiphoid process. The sternum is fully split by a sternal saw.
Medication. All participants are prescribed dual antiplatelet therapy with aspirin 100 mg plus clopidogrel 75 mg daily from the first day post-CABG until 3 months post-operation. Prescription of other concomitant medications such as β-blockers, statins, and antihypertensive agents is determined by local surgeons according to ACC/AHA guidelines.
The trial data will be analyzed on an intention-to-treat basis with patients included in the groups assigned at randomization, irrespective of future management and events.Demographic and clinical variables will be summarized as means (SDs) for continuous and counts (percentages) for categorical variables. Comparisons across the groups will be performed using a 2-tailed unpaired t test for continuous variables and the Pearson's χ2 test for categorical variables. A P value of less than 0.05 will be considered as statistically significant for all analyses.
Clinical events committee. All clinical events including myocardial infarction, stroke, target lesion revascularization, and death will undergo central adjudication by an independent clinical events committee (CEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inferior part-sternotomy CABG | Experimental | Procedure: Inferior part-sternotomyA midline skin incision of 8 to 10cm in length is made over the sternum, starting from 2-3cm below the sternal angle inferiorly and extending slightly beyond the xiphoid process. A sternal saw is used to split the sternum from the xiphoid process to the second intercostal space where the sternum is partially transected by turning the saw rightward. Left internal mammary artery (LIMA)-left anterior descending branch bypass is the first choice for all patients. Remaining coronary bypassing techniques are according to clinical practice and preference of the operator. If it is difficult to perform CABG via inferior part-sternotomy, the treatment strategy convert to full median sternotomy, which is deemed to be failed to achieve complete revascularization via inferior part-sternotomy. |
| Full median sternotomy CABG | Active comparator | Procedure: Full median sternotomyA midline skin incision is made over the sternum, starting from the sternal angle and extending slightly beyond the xiphoid process. The sternum is fully split by a sternal saw. Remaining coronary bypassing techniques are same in both groups according to clinical practice and preference of the operator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo primary isolated open-chest CABG with multi-vessel coronary disease(left main artery disease with right coronary artery disease,or three-vessel disease)
Key exclusion criteria (11 listed)
- Single vessel disease, double vessel disease, left main artery disease without right coronary artery disease.
- Concomitant cardiac surgeries(i.e. valve repair or replacement, Maze surgery, left ventricular repair due to ventricular aneurysm).
- Redo CABG.
- Emergent CABG.
- Left ventricular ejection fraction(EF≤35%).
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 |
|---|---|---|
| Inferior part-sternotomyA midline skin incision of 8 to 10cm in length is made over the sternum, starting from 2-3cm below the sternal angle inferiorly and extending slightly beyond the xiphoid process. A sternal saw is used to split the sternum from the xiphoid process to the second intercostal space where the sternum is partially transected by turning the saw rightward. | Procedure or surgery | Inferior part-sternotomy CABG |
| Full median sternotomyA midline skin incision is made over the sternum, starting from the sternal angle and extending slightly beyond the xiphoid process. The sternum is fully split by a sternal saw. | Procedure or surgery | Full median sternotomy CABG |
Primary outcome
Complete revascularization rate immediately after surgery
Time frame: Immediately after surgery
Most surgical groups have adopted the functional definition in their studies. We therefore elected to use a functional definition for complete revascularization in the present study. The coronary vascular tree was divided into 3 separate territories: the left anterior descending artery (LAD), the circumflex artery, and the right coronary artery (RCA).Functional completeness of revascularization is defined as all viable myocardial territories are reperfused, as at least one bypass graft for every diseased primary arterial territory
7 secondary outcomes
The harvest time of left Internal mammary artery (LIMA)
Time frame: During surgery
Aortic cross-clamp time
Time frame: During surgery
Overall operation time
Time frame: During surgery
Intraoperative real-time blood flow at each anastomosis
Time frame: During surgery
The total amount of postoperative chest tube drainage
Time frame: Up to 4 weeks
The graft patency rate by CTA at 5-7 days, 1 year, 3 years, 5 years, and 10 years after surgery
Time frame: 1week after the surgery；10 years after surgery
The rate of major adverse cardiac or cerebrovascular events (MACCE) at 5-7 days, 1 year, 3 years, 5 years, and 10 years after surgery
Time frame: 1week after the surgery；10 years 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 28 Apr 2023.
- Background: PubMed 30165437Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
- Background: PubMed 21393011Lapierre H, Chan V, Sohmer B, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting via a small thoracotomy versus off-pump: a case-matched study. Eur J Cardiothorac Surg. 2011 Oct;40(4):804-10. doi: 10.1016/j.ejcts.2011.01.066. Epub 2011 Mar 9.
- Background: PubMed 16847164Ong AT, Serruys PW. Complete revascularization: coronary artery bypass graft surgery versus percutaneous coronary intervention. Circulation. 2006 Jul 18;114(3):249-55. doi: 10.1161/CIRCULATIONAHA.106.614420. No abstract available.
- Background: PubMed 34533240Veiga Oliveira P, Madeira M, Ranchordas S, Marques M, Almeida M, Sousa-Uva M, Abecasis M, Neves JP. Complete surgical revascularization: Different definitions, same impact? J Card Surg. 2021 Dec;36(12):4497-4502. doi: 10.1111/jocs.15986. Epub 2021 Sep 16.
- Background: PubMed 36334649Sohn SH, Kang Y, Kim JS, Paeng JC, Hwang HY. Impact of Functional vs Anatomic Complete Revascularization in Coronary Artery Bypass Grafting. Ann Thorac Surg. 2023 Apr;115(4):905-912. doi: 10.1016/j.athoracsur.2022.10.029. Epub 2022 Nov 9.
- Background: PubMed 16551816Sun HS, Ma WG, Xu JP, Sun LZ, Lu F, Zhu XD. Minimal access heart surgery via lower ministernotomy: experience in 460 cases. Asian Cardiovasc Thorac Ann. 2006 Apr;14(2):109-13. doi: 10.1177/021849230601400206.
- Background: PubMed 15942568Kleisli T, Cheng W, Jacobs MJ, Mirocha J, Derobertis MA, Kass RM, Blanche C, Fontana GP, Raissi SS, Magliato KE, Trento A. In the current era, complete revascularization improves survival after coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2005 Jun;129(6):1283-91. doi: 10.1016/j.jtcvs.2004.12.034.
- Derived from this study: PubMed 42276410Ju F, Li B, Wu H, Sun H. Achieving completed revascularization via inferior mini-sternotomy versus conventional median sternotomy for CABG in patients with multivessel CAD (the ACRIS-MICABG trial): Rationale and design of a multicentre, randomized controlled trial. Contemp Clin Trials. 2026 Aug;167:108362. doi: 10.1016/j.cct.2026.108362. Epub 2026 Jun 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior part-sternotomy and Full median sternotomy in people with Complete Revascularization and Coronary Artery Bypass Grafting, run by China National Center for Cardiovascular Diseases.
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 1 inclusion and 11 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete revascularization rate immediately after surgery (time frame: Immediately after 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 NCT05835167, which also lists 8 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 28 Apr 2023.