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

Primary Purpose

Ischemia, Angina

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

St. Jude Medical Pressure Wire

ACIST Navvus Microcatheter

About this trial

This is an interventional diagnostic trial for Ischemia focused on measuring Ischemia, Fractional Flow Reserve, Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Columbia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pressure wire and Microcatheter

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02648230

First Posted

December 23, 2015

Last Updated

June 13, 2019

Sponsor

Columbia University

Collaborators

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT02648230

Brief Title

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

Acronym

PERFORM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 8, 2016 (Actual)

Study Completion Date

December 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemia, Angina

Keywords

Ischemia, Fractional Flow Reserve, Stent

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pressure wire and Microcatheter

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

St. Jude Medical Pressure Wire

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

ACIST Navvus Microcatheter

Other Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Fractional Flow Reserve (FFR)

Description

Time Frame

Through study completion (an average of an hour)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ajay Kirtane, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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

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