NCT04795193

MInithoraCotomy vs Sternotomy for Multivessel Coronary Artery Bypass Grafting: A Partially Randomized Patient Preference Trial Assessing Quality of Life and Patency Outcomes

ENROLLING BY INVITATION NA Last updated 16 September 2025

What this trial tests

NA trial testing Minimal invasive coronary surgery in Coronary Artery Bypass, Off-Pump in 248 participants. Enrolling by invitation.

Timeline

15 April 2021

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Peking University Third Hospital
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	248
Start date	15 April 2021
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

• Minimal invasive coronary surgery
• Off-pump coronary artery bypass surgery

Conditions studied

• Coronary Artery Bypass, Off-Pump — all drugs for Coronary Artery Bypass, Off-Pump →
• Minimally Invasive Cardiac Surgery — all drugs for Minimally Invasive Cardiac Surgery →

Sponsor

Peking University Third Hospital

Who can join

Adults 25 to 85, any sex, with Coronary Artery Bypass, Off-Pump or Minimally Invasive Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial will address essential questions of the efficacy and safety of MICS-CABG in addition to the quality of life and patency rate of the grafts. The study will also address the impact of patients' preferences on external validity and internal validity. In this study, patients with a preference will be allocated to treatment strategies accordingly, whereas only those patients without a distinct preference will be randomized. The randomized trial is a 248-patient controlled, randomized, investigator-blinded trial. It is designed to compare whether treatment with MICS-CABG is beneficial in comparison to CABG. This study is aimed to establish the superiority hypothesis for the physical component summary (PCS) accompanied by the noninferiority hypothesis for overall graft patency. Patients with no treatment preference will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoints are the PCS score at 30 days (1 month) after surgery and the overall patency rate of the grafts within 14 days ( before discharge) after surgery. Secondary outcome measures include the PCS score and patency rate at different time points. Safety endpoints include major adverse cardiac and cerebrovascular events, complications, bleeding, wound infection, death, etc.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Partially Randomized Patient Preference Trial to Assess the Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting: Design and Rationale of the MICS-CABG PRPP Trial.
   Gong Y, Wang X, Li N, Fu Y, et al · · 2022 · cited 4× · PMID 35548423 · DOI 10.3389/fcvm.2022.804217
2. Correction: A partially randomized patient preference trial to assess the quality of life and patency rate after minimally invasive cardiac surgery-coronary artery bypass grafting: design and rationale of the MICS-CABG PRPP trial.
   Gong Y, Wang X, Li N, Fu Y, et al · · 2025 · PMID 41246020 · DOI 10.3389/fcvm.2025.1713150