Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
NCT ID: NCT04854070
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2020 participants
INTERVENTIONAL
2021-11-02
2026-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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IVUS-guided PCI
Method is already used in standard care, but in this trial compared to another method also already used in standard care
IVUS
IVUS-guided approach in patients with complex coronary lesions undergoing PCI
Angio-guided PCI
Method is standard care
Angio
Angio-guided approach in patients with complex coronary lesions undergoing PCI
Interventions
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IVUS
IVUS-guided approach in patients with complex coronary lesions undergoing PCI
Angio
Angio-guided approach in patients with complex coronary lesions undergoing PCI
Eligibility Criteria
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Inclusion Criteria
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
3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
4. All lesions must be suitable for treatment with the Synergy stent system, Synergy Megatron system, or other Synergy platform iteration
5. The patient is willing and able to cooperate with study procedures and follow-up until study completion
6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee
Exclusion Criteria
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. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants
5. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
6. Non-cardiac co-morbidities with a life expectancy less than 1 year
7. 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
8. Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding
9. Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Cardialysis B.V.
INDUSTRY
ECRI bv
INDUSTRY
Responsible Party
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Principal Investigators
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R. Diletti, Dr.
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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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
CHRU Tours - HopitalTrousseau
Tours, , France
Segeberger Kliniken
Bad Segeberg, , Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Heart Center Dresden
Dresden, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
University of Giessen
Giessen, , Germany
MediClin Heartcenter Lahr
Lahr, , Germany
University of Ferrara
Ferrara, , Italy
Humanitas Research Hospital
Milan, , Italy
Ospedale degli infermi di Rivoli
Rivoli, , Italy
Ospedale dell'Angelo
Venezia, , Italy
Noordwest Hospital Group
Alkmaar, , Netherlands
VuMC
Amsterdam, , Netherlands
Albert Schweitzer hospital
Dordrecht, , Netherlands
Catharina hospital
Eindhoven, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Bellvitge University Hospital
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Reina Sofia Hospital
Córdoba, , Spain
Hospital la Paz
Madrid, , Spain
La Princesa University Hospital
Madrid, , Spain
Marques de Valdecilla University Hospital
Santander, , Spain
University Clinical Hospital of Valladolid
Valladolid, , Spain
Royal Victoria Hospital
Belfast, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
St. George's University Hospital
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Diletti R, Daemen J, Faurie B, Barbierato M, Tchetche D, Hovasse T, Teeuwen K, Oemrawsingh RM, Allali A, Campo G, Bennett J, Alfonso F, Mashayekhi K, Moreno R, Abdelwahed YS, Dedic A, de la Torre Hernandez JM, Murphy JC, Amat-Santos I, Dens J, Franze A, Leistner D, Ghattas A, Spratt JC, Banning AP, Tijssen JGP, Spitzer E, Van Mieghem NM; IVUS CHIP investigators. Intravascular ultrasound guidance for complex high-risk indicated procedures: The IVUS CHIP trial study design. Am Heart J. 2026 Jan 3;294:107339. doi: 10.1016/j.ahj.2026.107339. Online ahead of print.
Other Identifiers
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ECRI-14
Identifier Type: -
Identifier Source: org_study_id
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