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

Ischemia Clinical Trial

— PERFORM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648230
• Other study ID #: AAAQ1712
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 8, 2016

Study information

• Verified date: June 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 8, 2016
• Est. primary completion date: December 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina
• Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)