Complex Coronary LesionsIVUS-CHIPNCT04854070
Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
A study testing IVUS and Angio in people with Complex Coronary Lesions, run by ECRI bv at 37 sites in 7 countries.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Coronary Lesions
- What is being tested?
- IVUS and Angio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,020 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 2 Nov 2021to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
France7 sites
Clinique Saint-Augustin
Bordeaux
Cardiovascular Institute of Grenoble, GHM
Grenoble
Hopital Privé Jacques Cartier
Massy
Centre Cardiologique du Nord Saint-Denis
Saint-Denis
CHU
Toulouse
Clinique Pasteur
Toulouse
CHRU Tours - HopitalTrousseau
Tours
Spain7 sites
Bellvitge University Hospital
Barcelona
Hospital Clinic de Barcelona
Barcelona
Reina Sofia Hospital
Córdoba
Hospital la Paz
Madrid
La Princesa University Hospital
Madrid
Marques de Valdecilla University Hospital
Santander
University Clinical Hospital of Valladolid
Valladolid
Germany6 sites
Segeberger Kliniken
Bad Segeberg
Charite Universitatsmedizin Berlin
Berlin
Heart Center Dresden
Dresden
Universitätsklinikum Frankfurt
Frankfurt
University of Giessen
Giessen
MediClin Heartcenter Lahr
Lahr
Netherlands5 sites
Noordwest Hospital Group
Alkmaar
VuMC
Amsterdam
Albert Schweitzer hospital
Dordrecht
Catharina hospital
Eindhoven
Erasmus University Medical Center
Rotterdam
Belgium4 sites
OLVZ
Aalst
CHU
Charleroi
ZOL Sint-Jan
Genk
University Hospital Gasthuisberg
Leuven
Italy4 sites
University of Ferrara
Ferrara
Humanitas Research Hospital
Milan
Ospedale degli infermi di Rivoli
Rivoli
Ospedale dell'Angelo
Venezia
United Kingdom4 sites
Royal Victoria Hospital
Belfast
Golden Jubilee National Hospital
Glasgow
St. George's University Hospital
London
John Radcliffe Hospital
Oxford
About this study
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.
Read the 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.
- Conditions
- Complex Coronary Lesions
- Being tested
- IVUS, Angio
- Keywords
- Percutaneous coronary intervention, Angiographic guided PCI, Intra-vascular ultrasound guided PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUSDevice
IVUS-guided approach in patients with complex coronary lesions undergoing PCI
AngioDevice
Angio-guided approach in patients with complex coronary lesions undergoing PCI
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: IVUS |
| Angio-guided PCI | Active comparator | Method is standard care Receives: Device: Angio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start2 Nov 2021
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Coronary LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI
- Masking
- None (open label)
- Enrolment
- 2,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECRI bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Cardialysis B.V.
- Responsible party
- Sponsor
- Investigators
- R. Diletti, Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854070
- Sponsor's protocol ID
- ECRI-14
- Acronym
- IVUS-CHIP
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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 Jun 11;394(22):2200-2211. doi: 10.1056/NEJMoa2601521. Epub 2026 Mar 30.
PubMed 41911016Diletti 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.
PubMed 41490527
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
- ClinicalTrials.gov ID
- NCT04854070
- Acronym / sponsor ID
- IVUS-CHIP / ECRI-14
- Conditions
- Complex Coronary Lesions
- Keywords
- Percutaneous coronary intervention, Angiographic guided PCI, Intra-vascular ultrasound guided PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,020 participants (actual)
- Lead sponsor
- ECRI bvIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Cardialysis B.V.
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided PCI | Experimental | Device: IVUSMethod is already used in standard care, but in this trial compared to another method also already used in standard care |
| Angio-guided PCI | Active comparator | Device: AngioMethod is standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUSIVUS-guided approach in patients with complex coronary lesions undergoing PCI | Device | IVUS-guided PCI |
| AngioAngio-guided approach in patients with complex coronary lesions undergoing PCI | Device | Angio-guided PCI |
Primary outcome
Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Target-vessel failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
6 secondary outcomes
Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Clinically-indicated target vessel revascularization
Time frame: 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
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Target-Lesion Failure (TLF)
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Target-lesion revascularization
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Cardiac death
Time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: PubMed 41911016Diletti 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 Jun 11;394(22):2200-2211. doi: 10.1056/NEJMoa2601521. Epub 2026 Mar 30.
- Results publication: PubMed 41490527Diletti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Diletti, Dr. principal investigator
Erasmus Medical Center
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS and Angio in people with Complex Coronary Lesions, run by ECRI bv at 37 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Spain, Germany, Netherlands, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions (time frame: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854070, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.