Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (NCT05491668) | Clinical Trial Compass
RecruitingNot Applicable
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI
United States107 participantsStarted 2022-10-11
Plain-language summary
Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized.
The purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement/PCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.
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:
* Age \>/= 18 years
* Patient provides written informed consent
* Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI))
* Scheduled for clinically indicated cardiac catheterization
* At least one lesion with angiographic severity visually estimated to be \>/= 70% diameter stenosis that is deemed suitable for PCI
* The operator plans to perform PCI on an ad hoc or planned basis
* The target lesion is not planned for assessment by invasive physiology
Exclusion Criteria:
* Failure to provide signed informed consent
* Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI)
* Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
* Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus
* Chronic total occlusion (CTO) in the target vessel
* Target vessel is supplied by major collaterals or supplies major collaterals to a CTO
* Target lesion involves the left main coronary artery
* Prior history of coronary artery bypass grafting (CABG) to the target vessel, except if bypass graft is occluded
* Previously known untreated severe valvular heart disease
* Previously known left ventricular ejection fraction \<30%
* Sustained ventricular arrhythmias
* Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheteri…
Questions worth asking your doctor
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
The percentage of physiologically non-significant lesions observed
Timeframe: Time of procedure
2
Correlation of the operator visual angiographic assessment of stenosis severity with quantitative coronary angiography (QCA) and resting non-hyperemic pressure resting indices (NHPR)