Assessing the significance of severe coronary artery blockages before PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the physiological significance of coronary lesions that are visually assessed as severely blocked and are planned for percutaneous coronary intervention (PCI). It employs blinded physiological assessments both before and after the PCI procedure to determine the actual impact of these lesions on blood flow. The study aims to enhance the understanding of how invasive physiological testing can improve outcomes in patients undergoing PCI, particularly for lesions deemed severe by traditional angiographic methods. By utilizing advanced pressure-sensing technology, the study seeks to validate the effectiveness of non-hyperemic pressure ratio assessments in this context.

Why it matters

Who can join: the full rules

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 catheterization laboratory protocol)

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Eric Osborn, MD, PhD — Beth Israel Deaconess Medical Center
• Study coordinator: Eric Osborn, MD, PhD
• Email: eosborn@bidmc.harvard.edu
• Phone: 617-632-7452

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.