Recruiting

MiECC vs. Conventional

Sponsor:

Aristotle University Of Thessaloniki

Code:

NCT05487612

Conditions

Coronary Artery Disease

Aortic Valve Stenosis

Extracorporeal Circulation; Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Minimal Invasive Extracorporeal Circulation

Conventional cardiopulmonary bypass

Study Details

Brief summary:

MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.

Conditions

Coronary Artery Disease

Aortic Valve Stenosis

Extracorporeal Circulation; Complications

Study ID

NCT05487612

Start date

May 26, 2022

Status verified date

Mar, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest.

Exclusion Criteria:

  • Requirement for emergency or salvage operation.
  • Requirement for major aortic surgery (e.g. aortic root replacement).
  • Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products.
  • Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded).
  • Inability to give informed consent for the study (e.g. learning or language difficulties).

Study Design

Enrollment

1300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Minimal Invasive Extracorporeal Circulation (MiECC)

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with Minimal Invasive Extracorporeal Circulation (MiECC).

active comparator: Conventional Cardiopulmonary Bypass (cCPB)

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with conventional cardiopulmonary bypass (cCPB)

Interventions

Minimal Invasive Extracorporeal Circulation

Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).

Conventional cardiopulmonary bypass

Cardiac surgery with conventional cardiopulmonary bypass (cCPB).

Primary outcome measure

  • Composite outcome of postoperative serious adverse events [ Time Frame: 30 days after randomization following the index admission ]

Central Contacts and Locations

Central contacts

Georgios Papazisis, Assoc. Prof.

+30 2310999323papazisg@auth.gr

Locations

Perfusion Services University Health Network, Toronto General Hospital

Recruiting

Toronto, Canada, M5G 2C4

Contacts

Vivek Rao

Vivek.Rao@uhn.ca

Mousumi Mahanta

416-340-4800mailto:mousumi.mahanta@uhn.ca

More Information

Sponsor

Aristotle University Of Thessaloniki

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Cardiopulmonary bypass
  • Extracorporeal circulation
  • Minimal invasive extracorporeal circulation
  • Coronary artery bypass grafting
  • Aortic valve replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aristotle University Of Thessaloniki on 2026-03-30.