NCT05504031

Brief Summary

Coronary artery disease often necessitates complex interventions like coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with stents. Hybrid coronary revascularization, a minimally invasive approach, integrates both methods for complete revascularization. This multicenter randomized trial involves 1200 patients, comparing hybrid coronary revascularization to CABG in a 1:1 ratio. Eligible participants have multi-vessel coronary disease and are referred for elective or sub-acute CABG. Inclusion criteria include age 18 or older, significant multi-vessel disease, and potential complete revascularization with both methods. Exclusion criteria include chronic kidney disease, pregnancy, contradiction to dual antiplatelet therapy, recent myocardial infarction, and acute revascularization. The hybrid group undergoes staged revascularization, combining minimally invasive grafting of the left interior mammary artery to the left anterior descending artery with PCI-stenting of remaining lesions. The control group undergoes conventional CABG with sternotomy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, or unplanned hospitalization, while secondary outcomes include periprocedural complications, cardiovascular mortality, hospital-free days within 90 days, angina frequency, and quality of life. Evaluation occurs 12 months after randomization. The trial commences in 2024, with inclusion expected to conclude in 5 years.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,048

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
212mo left

Started Jul 2026

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
3 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
3.9 years until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
14 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2044

Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

August 15, 2022

Last Update Submit

June 1, 2026

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseHybrid coronary revascularizationPCICABG

Outcome Measures

Primary Outcomes (1)

  • A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization

    A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization

    12 months after randomization

Secondary Outcomes (4)

  • Angina symptoms

    12 months after randomization

  • Health related quality of life

    12 months after randomization

  • Hospital free days

    90 days after randomization

  • Procedural complications

    12 months after randomization

Study Arms (2)

Hybrid Group

EXPERIMENTAL

Complete revascularisation through a combined MIDCAB (LIMA-LAD graft trough a minimal invasive left anterior thoracotomy) and PCI (of all non-LAD stenoses)

Procedure: Hybrid coronary revascularization

CABG Group

ACTIVE COMPARATOR

Conventional CABG through a sternotomy

Procedure: Conventional revascularization

Interventions

Hybrid coronary revascularizationPROCEDURE

Coronary revascularization is conducted as a combined MIDCAB (LIMA-LAD grafting through a minimally invasive anterior left thoracotomy) and PCI (of all non-LAD stenoses)

Hybrid Group
Conventional revascularizationPROCEDURE

Conventional revascularization with CABG of all significant stenoses through a sternotomy

CABG Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • ≥ 18 years of age
  • Functionally significant MVD, defined as ≥ 70% diameter stenosis by visual estimation or functionally significant stenosis (FFR \< 0.80, non-hyperaemic index (iFR) \< 0.89) in at least two of the major epicardial vessels or major side branches
  • Patient history reviewed by both cardiac surgeon and cardiologist who in agreement find both CABG and hybrid revascularisation indicated and technically feasible with an expectation of complete revascularisation of all functionally significant stenoses in the LAD and at least one other coronary artery ≥ 2.5mm in diameter or left main bifurcation stenosis with functionally significant stenoses in both the LAD and left circumflex artery.

You may not qualify if:

  • Chronic kidney disease with estimated glomerular filtration rate \< 20 mL/min/kg
  • Pregnancy
  • Left main stenosis without additional functionally significant stenoses in both the LAD and the LCX
  • Contraindications to the use of dual antiplatelet therapy
  • STEMI within 1 month
  • Indication for acute revascularization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UZ Leuven

Leuven, Belgium

Location

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Christian Carranza, MD, E-MBA

    Department of Cardiothoracic Surgery, Copenhagen University Hospital, Denmark

    STUDY DIRECTOR

Central Study Contacts

Erika Nodin, MD

CONTACT

004535451172enod0001@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
We intend to blind all possible trial personal. Participants and care providers can not be blinded due to obvious scaring on the patient and the hospital ward (department) that is responsible for patient care.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomisation to Hybrid coronary revascularisation (MIDCAB+PCI) or CABG
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

July 15, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2044

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

We plan to make all data publicly available in peer-review papers, after the trial has been finalized.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
At the end of the trial
Access Criteria
In peer-review papers

Locations

NL(1)BE(1)DK(1)