NCT05333068

COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,222 (estimated)
• Sponsor: Diagram B.V. · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.

Detailed description

The published COMBINE trial shows that patients carrying an OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia. The most important finding of this trial is that not ischemia, but underlying lesion morphology could be the most important factor that predicts future adverse events. Together with the recently published ISCHEMIA trial, where ischemia guided revascularization failed to improve clinical outcomes compared to medical treatment, the COMBINE trial leads to a new way of thinking in interventional cardiology and also opens the door for new treatment strategies where a combined ischemic and morphologic assessment could lead to better clinical outcomes. The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation. The COMBINE-INTERVENE Trial is the first in line trial that will test focal percutaneous stenting for vulnerable plaque lesions independently from ischemia.

Conditions

• Multivessel Coronary Artery Disease
• Ischemia
• Vulnerable Plaque
• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	PCI revascularization strategy based on combined FFR and OCT assessment	PCI revascularization strategy based on combined FFR and OCT assessment All FFR ≤ 0.75 and Vulnerable plaque will be treated. VP defined as TCFA ( cap thickness ≤ 75 micron); Ruptured plaque; or Plaque erosion with \> 70 % AS or MLA \< 2.5 mm2.
PROCEDURE	PCI revascularization strategy based FFR assessment	PCI revascularization strategy based FFR assessment (all lesions with FFR≤0.80 will be treated)

Timeline

• Start date: 2022-03-16
• Primary completion: 2026-03-16
• Completion: 2026-12-31
• First posted: 2022-04-18
• Last updated: 2025-02-04

Locations

49 sites across 18 countries: Australia, Canada, Denmark, Estonia, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Romania, Slovakia, Spain, Sweden, Taiwan