Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

NCT04854070 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ECRI-14
• Study Type: interventional
• Target: 2,020
• Locations: 7 countries
• Sites: 37

Brief 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

Keywords

Percutaneous coronary intervention; Angiographic guided PCI; Intra-vascular ultrasound guided PCI

Outcome Measures

Primary Outcomes (1)

• Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions

  Target-vessel failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

Secondary Outcomes (6)

• Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

• Clinically-indicated target vessel revascularization

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

• Composite of cardiac death and target-vessel myocardial infarction

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

• Target-Lesion Failure (TLF)

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

• Target-lesion revascularization

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

Other Outcomes (14)

• Patient-Oriented Composite Endpoint

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

• Device-Oriented Composite Endpoint

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

• Target Vessel Revascularization

  From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

Study Arms (2)

IVUS-guided PCI

EXPERIMENTAL

Method is already used in standard care, but in this trial compared to another method also already used in standard care

Device: IVUS

Angio-guided PCI

ACTIVE COMPARATOR

Method is standard care

Device: Angio

Interventions

IVUS DEVICE

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

IVUS-guided PCI

Angio DEVICE

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

Angio-guided PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following:
• The patient must be ≥18 years of age
• Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
• Angiographic heavy calcification
• Ostial lesions
• True bifurcation lesions involving side-branches \>2.5mm
• Left main lesions
• Chronic total occlusion
• In-stent restenosis
• 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
• Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
• All lesions must be suitable for treatment with the Synergy stent system, Synergy Megatron system, or other Synergy platform iteration
• The patient is willing and able to cooperate with study procedures and follow-up until study completion
• 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

You may not qualify if:

• Any of the following:
• ST-elevation myocardial infarction, cardiogenic shock
• Known untreated severe valvular heart disease
• IVUS is strictly required for pre-PCI lesion severity assessment
• Requiring PCI in a diseased aorto-coronary bypass
• Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants
• Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
• Non-cardiac co-morbidities with a life expectancy less than 1 year
• 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
• Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding
• Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write

Sponsors & Collaborators

• ECRI bv: lead
• Boston Scientific Corporation: collaborator
• Cardialysis B.V.: collaborator

Study Sites (37)

OLVZ

Aalst, Belgium

Location

CHU

Charleroi, Belgium

Location

ZOL Sint-Jan

Genk, Belgium

Location

University Hospital Gasthuisberg

Leuven, Belgium

Location

Clinique Saint-Augustin

Bordeaux, France

Location

Cardiovascular Institute of Grenoble, GHM

Grenoble, France

Location

Hopital Privé Jacques Cartier

Massy, France

Location

Centre Cardiologique du Nord Saint-Denis

Saint-Denis, France

Location

CHU

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

CHRU Tours - HopitalTrousseau

Tours, France

Location

Segeberger Kliniken

Bad Segeberg, Germany

Location

Charite Universitatsmedizin Berlin

Berlin, Germany

Location

Heart Center Dresden

Dresden, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

University of Giessen

Giessen, Germany

Location

MediClin Heartcenter Lahr

Lahr, Germany

Location

University of Ferrara

Ferrara, Italy

Location

Humanitas Research Hospital

Milan, Italy

Location

Ospedale degli infermi di Rivoli

Rivoli, Italy

Location

Ospedale dell'Angelo

Venezia, Italy

Location

Noordwest Hospital Group

Alkmaar, Netherlands

Location

VuMC

Amsterdam, Netherlands

Location

Albert Schweitzer hospital

Dordrecht, Netherlands

Location

Catharina hospital

Eindhoven, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Bellvitge University Hospital

Barcelona, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Reina Sofia Hospital

Córdoba, Spain

Location

Hospital la Paz

Madrid, Spain

Location

La Princesa University Hospital

Madrid, Spain

Location

Marques de Valdecilla University Hospital

Santander, Spain

Location

University Clinical Hospital of Valladolid

Valladolid, Spain

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

St. George's University Hospital

London, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (2)

• 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 Apr;294:107339. doi: 10.1016/j.ahj.2026.107339. Epub 2026 Jan 3.

  PMID: 41490527 RESULT

• Diletti R, Daemen J, Faurie B, Barbierato M, Tchetche D, Hovasse T, Teeuwen K, Cheng JM, Landt M, Campo G, Bennett J, Alfonso F, Mashayekhi K, Moreno R, Abdelwahed YS, Heestermans T, de la Torre Hernandez JM, Murphy JC, Amat-Santos I, Dens J, Franze A, Leistner DM, Ghattas A, Spratt JC, Banning AP, Tijssen JGP, Spitzer E, Van Mieghem NM; IVUS-CHIP Investigators. Intravascular Ultrasound-Guided or Angiography-Guided Complex High-Risk PCI. N Engl J Med. 2026 Mar 30. doi: 10.1056/NEJMoa2601521. Online ahead of print.

  PMID: 41911016 DERIVED

Study Officials

• R. Diletti, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 22, 2021
• Study Start: November 2, 2021
• Primary Completion: July 17, 2024
• Study Completion: March 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); DE (6); BE (4); IT (4); FR (7); NL (5); ES (7)