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Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

Recruiting · NCT05491668

Conditions: Coronary Artery Disease

At a glance

Research payments reported, 2025
$15,618
U.S. investigators named
2
Sites paid
2
Planned or actual enrollment
107

About the trial

Sponsor
Beth Israel Deaconess Medical Center (with Opsens, Inc.)
Tested
Non-hyperemic pressure ratio assessment pre and post PCI (diagnostic_test)
Dates
Started 2022-10-11; completion 2027-06
Results posted
Not yet

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 purp…

From ClinicalTrials.gov, last updated 2026-06-11. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Cardiva Medical, Inc. reported $15,618 in research payments for this study in 2025 (3 payments).

Products named: Optowire

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.