Complete Revascularization Via Inferior Part-sternotomy

NCT05835167 | Not Yet Recruiting DMC

• 1 other identifier: 2022-GSP-GG-23
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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 revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China.

Conditions

Complete Revascularization; Coronary Artery Bypass Grafting; Multivessel Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Immediately after surgery

Secondary Outcomes (7)

• The harvest time of left Internal mammary artery (LIMA)

  During surgery

• Aortic cross-clamp time

  During surgery

• Overall operation time

  During surgery

• Intraoperative real-time blood flow at each anastomosis

  During surgery

• The total amount of postoperative chest tube drainage

  Up to 4 weeks

Study Arms (2)

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.

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.

Procedure: Full median sternotomy

Interventions

Inferior part-sternotomy PROCEDURE

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.

Inferior part-sternotomy CABG

Full median sternotomy PROCEDURE

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.

Full median sternotomy CABG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Tangshan Central Hospital: collaborator
• Baotou Central Hospital: collaborator
• Xiamen Second Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Peking University International Hospital: collaborator
• Shenzhen Sun Yat-sen Cardiovascular Hospital: collaborator
• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Henan Provincial People's Hospital: collaborator

Related Publications (7)

• 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.

  PMID: 30165437 BACKGROUND

• Lapierre 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.

  PMID: 21393011 BACKGROUND

• Ong 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.

  PMID: 16847164 BACKGROUND

• Veiga 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.

  PMID: 34533240 BACKGROUND

• Sohn 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.

  PMID: 36334649 BACKGROUND

• Sun 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.

  PMID: 16551816 BACKGROUND

• Kleisli 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.

  PMID: 15942568 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 28, 2023
• Study Start: May 5, 2023
• Primary Completion: May 4, 2025
• Study Completion (Estimated): May 4, 2035
• Last Updated: April 28, 2023

Record last verified: 2023-04