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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Cardialysis B.V. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Angio-guided PCI | Active Comparator | Method is standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS | Device | IVUS-guided approach in patients with complex coronary lesions undergoing PCI |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
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:
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
Exclusion Criteria:
Any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| R. Diletti, Dr. | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVZ | Aalst | Belgium | ||||
| CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41911016 | 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 Jun 11;394(22):2200-2211. doi: 10.1056/NEJMoa2601521. Epub 2026 Mar 30. | |
| 41490527 |
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Randomization in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI
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| Angio | Device | Angio-guided approach in patients with complex coronary lesions undergoing PCI |
|
| 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 |
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 |
| 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 |
| Result |
| 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. |