Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures (IVUS-CHIP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Complex Coronary Lesions
• Intervention / Treatment: Device: IVUS; Device: Angio

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.

• Study Type: Interventional
• Enrollment (Actual): 2020
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLVZ
  • Charleroi, Belgium
    • CHU
  • Genk, Belgium
    • ZOL Sint-Jan
  • Leuven, Belgium
    • University Hospital Gasthuisberg
• France
  • Bordeaux, France
    • Clinique Saint-Augustin
  • Grenoble, France
    • Cardiovascular Institute of Grenoble, GHM
  • Massy, France
    • Hôpital Privé Jacques Cartier
  • Saint-Denis, France
    • Centre Cardiologique du Nord Saint-Denis
  • Toulouse, France
    • Clinique Pasteur
  • Toulouse, France
    • CHU
  • Tours, France
    • CHRU Tours - HopitalTrousseau
• Germany
  • Bad Segeberg, Germany
    • Segeberger Kliniken
  • Berlin, Germany
    • Charite Universitatsmedizin Berlin
  • Dresden, Germany
    • Heart Center Dresden
  • Frankfurt, Germany
    • Universitätsklinikum Frankfurt
  • Giessen, Germany
    • University of Gießen
  • Lahr, Germany
    • MediClin Heartcenter Lahr
• Italy
  • Ferrara, Italy
    • University of Ferrara
  • Milan, Italy
    • Humanitas Research Hospital
  • Rivoli, Italy
    • Ospedale degli Infermi di Rivoli
  • Venezia, Italy
    • Ospedale dell'Angelo
• Netherlands
  • Alkmaar, Netherlands
    • Noordwest Hospital Group
  • Amsterdam, Netherlands
    • VUmc
  • Dordrecht, Netherlands
    • Albert Schweitzer Hospital
  • Eindhoven, Netherlands
    • Catharina Hospital
  • Rotterdam, Netherlands
    • Erasmus University Medical Center
• Spain
  • Barcelona, Spain
    • Hospital Clinic De Barcelona
  • Barcelona, Spain
    • Bellvitge University Hospital
  • Córdoba, Spain
    • Reina Sofía Hospital
  • Madrid, Spain
    • Hospital La Paz
  • Madrid, Spain
    • La Princesa University Hospital
  • Santander, Spain
    • Marqués de Valdecilla university hospital
  • Valladolid, Spain
    • University Clinical Hospital of Valladolid
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital
  • Glasgow, United Kingdom
    • Golden Jubilee National Hospital
  • London, United Kingdom
    • St. George's University Hospital
  • Oxford, United Kingdom
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
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:

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
10. Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVUS-guided PCI; Method is already used in standard care, but in this trial compared to another method also already used in standard care	Device: IVUS; IVUS-guided approach in patients with complex coronary lesions undergoing PCI
Active Comparator: Angio-guided PCI; Method is standard care	Device: Angio; Angio-guided approach in patients with complex coronary lesions undergoing PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization	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	Clinically-indiated target vessel revascularization is defined as any clinically-indicated repeat percutaneous intervention or surgical bypass of any segment of the target vessel	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	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)	Target-Lesion Failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Target-lesion revascularization	Target-lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Cardiac death	Cardiac death is defined as death resulting from cardiovascular causes	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Oriented Composite Endpoint	The Patient-Oriented Composite Endpoint (POCE) is defined as all-cause death, any stroke, any myocardial infarction, and any revascularization	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Device-Oriented Composite Endpoint	The Device-oriented Composite Endpoint (DOCE) is defined as the composite of: cardiovascular death, target-vessel MI, clinically indicated repeat revascularization of the target lesion	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Target Vessel Revascularization	Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Stroke	A focal or global neurological deficit for >24 hours; or <24 hours if available neuroimaging documents a new hemorrhage or infarct; or the neurological deficit results in death	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Definite or Probable Stent Thrombosis	Defined according to the Academic Research Consortium 2	From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Procedural time	Duration of the index percutaneous coronary intervention procedure in minutes	Index procedure
Total contrast volume	Total volume of contrast material used during the index percutaneous coronary intervention measured in milliliters	Index procedure
Device usage	Total number of coronary stents used during the index percutaneous coronary intervention	Index procedure
Acute Kidney Injury	Site-reported acute kidney function deterioration after percutaneous coronary intervention	Post-procedural and up to 30 days
Vascular Access Site Complications	Site-reported vascular access site complications related to the index percutaneous coronary intervention procedure	Peri and post-procedural and up to 30 days
Bleeding	Site-reported bleeding related to the index percutaneous coronary intervention procedure	Peri and post-procedural and up to 30 days
Major Intra-Procedural Complications	Defined as including Type C - F dissection (NHLBI), persistent slow-flow or persistent no-reflow, abrupt closure, distal embolization, thrombus, and major (≥2 mm vessel diameter) side branch occlusion	Index procedure
Coronary perforation	Coronary perforations classified according to the Ellis criteria	Index procedure
Achievement of optimal intravascular ultrasound criteria	Achievement of optimal IVUS criteria post-PCI was defined according to the following three criteria: final minimal stent area (MSA) > 5 mm2 or MSA > 90% of distal reference lumen; plaque burden <50% within 5 mm from the proximal or distal stent edge; no edge dissection involving the media and > 3 mm in length	Index procedure

Collaborators and Investigators

• Sponsor: ECRI bv
• Collaborators: Boston Scientific Corporation; Cardialysis B.V.
• Investigators: Principal Investigator: R. Diletti, Dr., Erasmus Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): July 17, 2024
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Angiographic guided PCI; Intra-vascular ultrasound guided PCI
• Other Study ID Numbers: ECRI-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes