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

NCT05333068 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1222

Last updated 2025-02-04

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Diagram B.V.

    lead OTHER

Principal Investigators

  • Elvin Kedhi, Prof.dr. · Professor of Medicine McGill University; Director Intervention Cardiology, McGill University Health Center, Canada; Visiting Professor, Silesian Medical University Katowice, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2026-03-16
Completion
2026-12-31

Countries

  • Australia
  • Canada
  • Denmark
  • Estonia
  • France
  • Germany
  • India
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • New Zealand
  • Poland
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333068 on ClinicalTrials.gov