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NCT Number: NCT02648230

PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements

The model by which physicians measure the lack of blood flow in the vessels that supply blood to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the pressure across the vessels that supply blood to the heart. These are known as the coronary arteries. This study involves comparing two FFR wires, the St. Jude Medical Pressure Wire (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the devices. FFR allows real-time estimation of the effects of a narrowed vessel, whereas standard angiography can underestimate or overestimate narrowing, because it only visualizes contrast (the different areas of color) inside a vessel.

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Key information

Conditions

Ischemia Angina Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

About this study

Fractional flow reserve (FFR) measurement by pressure wire (PW) under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated in several clinical outcomes studies as a way of optimizing case selection for percutaneous coronary intervention (PCI). More recently a microcatheter (MC)-based sensor measurement of fractional flow reserve has been introduced. Small scale in-vivo comparisons have been performed suggesting the utility of this approach to measure FFR,but these data are limited and have not been independently validated. This non-randomized, prospective study is designed to evaluate the accuracy of MC-based FFR measurement to the PW standard in lesions subjected to FFR assessment in routine clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Patient provides signed written informed consent before any study-specific procedure.
  • Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
  • Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery.
  • Undergoing FFR assessment for standard clinical or diagnostic indications

Exclusion criteria

  • Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
  • Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
  • Currently participating in another clinical study that interferes with study results.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
  • Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
  • High degree A-V block, sinus node disease.
  • Known hypersensitivity to adenosine

Treatment and study plan

St. Jude Medical Pressure Wire

Device

FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time

Other names: PW

ACIST Navvus Microcatheter

Device

FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time

Other names: MC

Primary outcomes

  1. Mean Fractional Flow Reserve (FFR)

    Time frame: Through study completion (an average of an hour)

    The mean FFR will be measured with the pressure catheter (PC) to be compared against the mean FFR measured with a standard Pressure Wire (PW) within the same subject across the same target lesion at the same time. Fractional flow reserve measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of cORonary Fractional Flow Reserve Measurements

Acronym: PERFORM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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