Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

NCT04854070•ECRI bv

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.

Detailed Description

During percutaneous coronary intervention (PCI) coronary arteries are visualized to guide placing the stent. In this study 2 currently utilized methods of visualizing coronary arteries during PCI are compared: intravascular ultrasound (IVUS) and angiographic guided PCI for patients with complex coronary lesions. The use of IVUS during PCI is suggested to give better results than angiographic guided PCI. The IVUS-CHIP trial is a randomized, controlled, multicenter, international, post-marketing study. A total of 2020 patients, in 7 European countries and approximately 40 hospitals, will be included, randomized in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI, and followed up for at least 2 years. The IVUS-CHIP is an event-driven study; primary analysis of the data will take place after at least 169 patients have experienced an event.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All of the following:
•1. The patient must be ≥18 years of age
•2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
•1. Angiographic heavy calcification
•2. Ostial lesions
•3. True bifurcation lesions involving side-branches \>2.5mm
•4. Left main lesions
•5. Chronic total occlusion
•6. In-stent restenosis
•7. Long-lesions (estimated stent length \> 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
+4 more criteria

Exclusion Criteria

•Any of the following:
•1. ST-elevation myocardial infarction, cardiogenic shock
•2. Known untreated severe valvular heart disease
•3. IVUS is strictly required for pre-PCI lesion severity assessment
•4. Requiring PCI in a diseased aorto-coronary bypass
•5. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants
•6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
•7. Non-cardiac co-morbidities with a life expectancy less than 1 year
•8. Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
•9. Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding
+1 more criteria

Locations (37)

OLVZ

Aalst, Belgium

CHU

Charleroi, Belgium

ZOL Sint-Jan

Genk, Belgium

University Hospital Gasthuisberg

Leuven, Belgium

Clinique Saint-Augustin

Bordeaux, France

Cardiovascular Institute of Grenoble, GHM

Grenoble, France

Hopital Privé Jacques Cartier

Massy, France

Centre Cardiologique du Nord Saint-Denis

Saint-Denis, France

CHU

Toulouse, France

Clinique Pasteur

Toulouse, France

Key Dates

Start Date

November 2, 2021

Primary Completion Date

July 17, 2024

Completion Date

March 30, 2026

Last Updated

March 4, 2026

Enrollment

2,020

ACTUAL participants

Conditions

Complex Coronary Lesions

Interventions

IVUS

DEVICE

Angio

DEVICE