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

NCT02648230 | Completed Results

• 1 other identifier: AAAQ1712
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia; Angina

Keywords

Ischemia; Fractional Flow Reserve; Stent

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Pressure wire and Microcatheter

EXPERIMENTAL

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; Device: ACIST Navvus Microcatheter

Interventions

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

Also known as: PW

Pressure wire and Microcatheter

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

Also known as: MC

Pressure wire and Microcatheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Ischemia; Angina Pectoris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ajay Kirtane, MD, SM
• Organization: Columbia University

akirtane@columbia.edu

212-305-7060

Study Officials

• Ajay Kirtane, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: December 8, 2016
• Study Completion: December 8, 2016
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Locations

US (1)