Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Eric Osborn, MD, PhD
eosborn@bidmc.harvard.edu
617-632-7452
Backup
Killian McCarthy, MB, BCh, BAO
kmccar10@bidmc.harvard.edu
617-632-0544
Time Frame
Start Date: 2022-10-11
Estimated Completion Date: 2026-06
Participants
Target number of participants: 107
Treatments
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.
Sponsors
Collaborators: Opsens, Inc.
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov