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

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

Study Overview

• Status: Completed
• Conditions: Ischemia; Angina
• Intervention / Treatment: Device: St. Jude Medical Pressure Wire; Device: ACIST Navvus Microcatheter

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pressure wire and Microcatheter; All subjects enrolled will have both an FFR done measured by a pressure wire (PW) and then again by a microcatheter (MC).

Device: St. Jude Medical Pressure Wire; 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; Device: ACIST Navvus Microcatheter; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Fractional Flow Reserve (FFR)	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.	Through study completion (an average of an hour)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Ajay Kirtane, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 8, 2016
• Study Completion (Actual): December 8, 2016

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Stent; Ischemia; Fractional Flow Reserve
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: AAAQ1712