Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05491668
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-hyperemic pressure ratio assessment pre and post PCI — DIAGNOSTIC_TEST
    Pre and post PCI invasive physiologic assessment

Study Details

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.

Key Dates

Start date
Oct 11, 2022
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
107 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

The percentage of physiologically non-significant lesions observed [ Time Frame: Time of procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Eric Osborn, MD, PhD
[email protected]
617-632-7452
Jenifer Kaufman, DNP, ANP-BC, BCPA
[email protected]
617-632-8956

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MA

Related Studies