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

NCT ID: NCT02648230

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-08

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.

Conditions

Ischemia; Angina

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

St. Jude Medical Pressure Wire

Intervention Type: 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

ACIST Navvus Microcatheter

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

PW; MC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Ajay Kirtane

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ajay Kirtane, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

AAAQ1712

Identifier Type: -

Identifier Source: org_study_id