The Ideal Sequence of Hybrid Coronary Revascularization with Endoscopic Coronary Revascularization

NCT05184075 | Terminated

• 1 other identifier: f/2021/085
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Hybrid coronary revascularization (HCR), a combination of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), has emerged as an alternative treatment for multivessel coronary artery disease patients. However, the ideal sequence (PCI or CABG) is unclear. The overall aim of this study is to investigate the best sequence within hybrid coronary revascularization using endoscopic coronary bypass grafting (i.e., first CABG then PCI versus first PCI then CABG)

Conditions

Coronary Artery Disease

Keywords

Hybrid coronary revascularization; Coronary revascularization

Outcome Measures

Primary Outcomes (1)

• 30-day net adverse clinical event (NACE)

  NACE consists of major adverse cardiac and cerebrovascular events (MACCE) and major bleeding unrelated to CABG (Bleeding Academic Research Consortium (BARC) type 3 and 5) MACCE consists of: * Death from any cause * Myocardial infarction * Stroke * Target lesion revascularisation

  From the first procedure until 30 days after the second procedure.

Secondary Outcomes (16)

• Key secondary outcome: 30-day major adverse cardiac and cerebrovascular events (MACCE)

  From the first procedure until 30 days after the second procedure

• Key secondary outcome: 30-day major or clinically relevant non-major bleeding (BARC type 2, 3, 4, 5)

  From the first procedure until 30 days after the second procedure

• Key secondary outcome: One-year net adverse clinical event (NACE)

  From the first procedure until one year after the second procedure

• Key secondary outcome: one-year major adverse cardiac and cerebrovascular events (MACCE)

  From the first procedure until one year after the second procedure

• Key secondary outcome: One-year major or clinically relevant non-major bleeding (BARC type 2, 3, 4, 5)

  From the first procedure until one year after the second procedure

Study Arms (2)

Reverse hybrid coronary revascularization (HCR)

ACTIVE COMPARATOR

Patients will undergo reverse hybrid coronary revascularization. Moreover, quality of life is assessed at baseline, 14 days, 30 days, 90 days, 6 months and 1 year.

Procedure: Reverse hybrid coronary revascularization

Standard hybrid coronary revascularization (HCR)

ACTIVE COMPARATOR

Patients will undergo standard hybrid coronary revascularization. Moreover, quality of life is assessed at baseline, 14 days, 30 days, 90 days, 6 months and 1 year.

Procedure: Standard hybrid coronary revascularization

Interventions

Standard hybrid coronary revascularization PROCEDURE

Patients will undergo endoscopic coronary artery bypass grafting (endo-CABG) within four weeks after the diagnostic coronarography. Furthermore, they will receive a percutaneous coronary intervention (PCI) within four weeks after the endo-CABG.

Standard hybrid coronary revascularization (HCR)

Reverse hybrid coronary revascularization PROCEDURE

Patients will receive a percutaneous coronary intervention (PCI) within four weeks after the diagnostic coronarography. Furthermore, they will undergo the endoscopic coronary artery bypass grafting (endo-CABG) within four weeks after the PCI.

Reverse hybrid coronary revascularization (HCR)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multivessel coronary disease, defined as ≥ 50% diameter stenosis by visual estimation in 2 or more of the three major epicardial vessels or major side branches, with at least one or more one stenosis amenable to revascularization with PCI, if the patient cannot be full revascularized by surgery for a specific reason as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis.
• Age 18-85
• Willing and able to provide informed, written consent

You may not qualify if:

• Requirement for other cardiac or non-cardiac surgical procedures (e.g., valve replacement, carotid revascularization)
• Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support at the time of randomisation
• Left main coronary artery disease
• Contraindication for dual antiplatelet therapy
• ST-Elevation Myocardial Infarction (STEMI)
• Previous cardiac surgery
• Participation in other interventional clinical trials
• Recent coronary intervention (PCI)
• Ongoing high risk non-ST-segment elevation acute coronary syndrome (ACS)
• Life expectancy \< 1 year
• Active bleeding more or equal to BARC 2 at time of randomisation
• Requiring renal replacement therapy
• Undergoing evaluation for organ transplantation

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yoann Bataille, PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: January 9, 2023
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)