Recruiting

Coronary Stenosis

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05491668

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-hyperemic pressure ratio assessment pre and post PCI

Study Details

Brief 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.

Conditions

Coronary Artery Disease

Study ID

NCT05491668

Start date

Oct 11, 2022

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

107 participants

Anticipated

Interventions and Outcome Measures

Arms

Coronary Physiology Assessment

Patients undergoing coronary angiogram who are found to have >/= 70% coronary stenosis and planned for percutaneous coronary intervention (PCI)/stent placement, will undergo pre and post PCI invasive physiologic assessment with a coronary pressure-sensing wire (OpSens OptoWire III) using non-hyperemic pressure ratio (NHPR) indices (diastolic pressure ratio \[dPR\]). Both the patient and interventional cardiologist will be blinded to the results of the invasive physiologic assessment. Angiogram co-registration will be performed on pullback of coronary pressure-sensing wire.

Interventions

Non-hyperemic pressure ratio assessment pre and post PCI

Pre and post PCI invasive physiologic assessment

Primary outcome measure

  • The percentage of physiologically non-significant lesions observed [ Time Frame: Time of procedure ]
  • Correlation of the operator visual angiographic assessment of stenosis severity with quantitative coronary angiography (QCA) and resting non-hyperemic pressure resting indices (NHPR) [ Time Frame: Within 30 days post procedure ]
  • Correlation between QCA and NHPR [ Time Frame: Within 30 days post procedure ]

Central Contacts and Locations

Central contacts

Jenifer Kaufman, DNP, ANP-BC, BCPA

617-632-8956jmkaufma@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jenifer Kaufman, DNP, ANP-BC, BCPA

617-632-8956jmkaufma@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Invasive physiology
  • Angiography
  • Percutaneous coronary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-06-11.