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Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

NCT04854070 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2020

Last updated 2026-03-04

No results posted yet for this study

Summary

The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or angiographic guided PCI .

The IVUS-guided PCI approach is indicated to reduce the frequency of target-lesion failure (cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization) in patients with complex coronary lesions undergoing PCI.

The objective of this study is to assess the superiority of an IVUS-guided approach versus an angio-guided approach in patients with complex coronary lesions undergoing PCI.

Conditions

  • Complex Coronary Lesions

Interventions

DEVICE

IVUS

IVUS-guided approach in patients with complex coronary lesions undergoing PCI

DEVICE

Angio

Angio-guided approach in patients with complex coronary lesions undergoing PCI

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Cardialysis B.V.

    collaborator INDUSTRY

  • ECRI bv

    lead INDUSTRY

Principal Investigators

  • R. Diletti, Dr. · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2024-07-17
Completion
2026-03-30
FDA Device
Yes

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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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 NCT04854070 on ClinicalTrials.gov