Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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 169 patients have experienced an event.

Official Title
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Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

Conditions
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Complex Coronary Lesions

Intervention / Treatment
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* Device: IVUS
* Device: Angio


Participation Criteria
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Eligibility Criteria
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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: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Angiographic guided PCI, Intra-vascular ultrasound guided PCI