NCT05491668Recruiting
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 107 (estimated)
- First submitted
- 5 Aug 2022
- Start date
- 11 Oct 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05491668
What you commit to
- Study type: Observational
- Planned participants: 107
- From 11 Oct 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Sustained ventricular arrhythmias
Lab values
- Previously known left ventricular ejection fraction \<30%
- Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheterization laboratory protocol)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.