Complex Coronary Lesions
Conditions
Keywords
Percutaneous coronary intervention, Angiographic guided PCI, Intra-vascular ultrasound guided PCI
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.
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.
Interventions
Sponsors
ECRI bv
Boston Scientific Corporation
Cardialysis B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomization in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Composite of target-vessel myocardial infarction and clinically indicated target vessel revascularization |
| 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-indiated target vessel revascularization is defined as any clinically-indicated repeat percutaneous intervention or surgical bypass of any segment of the target vessel |
| 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 | Composite of cardiac death and target-vessel myocardial infarction |
| 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 Failure is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization |
| 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 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 |
| Cardiac death | From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up | Cardiac death is defined as death resulting from cardiovascular causes |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORR. Diletti, Dr.
Erasmus Medical Center
Outcome results
None listed