Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
Belgium, France, Germany2,020 participantsStarted 2021-11-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared IVUS-guided PCI to angiography-guided PCI for complex coronary lesions — based on what this study found, does my specific type of lesion fall into the 'complex' category where IVUS guidance might make a difference in outcomes like target-vessel failure?
2Since this trial has already been completed, have the results been published, and if so, what did they show about whether IVUS guidance actually reduced the rate of target-vessel failure compared to standard angiography guidance?
3If the trial results suggest IVUS guidance is beneficial, is IVUS-guided PCI something your team already offers as a standard option, or would I need to be referred somewhere that routinely uses it for complex cases?
4This was a Phase NA study focused on comparing two guidance techniques rather than a new drug or device — does that mean the main question is about how my procedure is performed rather than whether there are unknown safety risks from an experimental treatment?
5Given that this trial is now completed and I was not part of it, how should its findings factor into the conversation about whether I should have PCI at all versus other treatment options like bypass surgery or medication management for my coronary lesions?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Target-vessel failure comparison of IVUS-guided PCI to angio-guided PCI in patients with complex coronary lesions
Timeframe: From date of randomization until the analysis cut-off date at approximately 15-18 months of median follow-up
. 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
. 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