NCT02577484

Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement

Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Acist Medical Systems · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

Detailed description

The ACIST-FFR study is a prospective, open label, observational, multi-center study designed to assess the differences, if any, between FFR measured by the Navvus catheter and a commercially available 0.014-inch pressure guidewire (St. Jude Medical, Volcano, hereafter referred to as the PW) in subjects with coronary artery disease (CAD) undergoing coronary angiography. This will be accomplished by comparing the FFR measurement obtained with the ACIST Medical Systems RXi System and Navvus catheter with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	RXi System	Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR. Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The RXi system includes a single use catheter (Navvus) with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired by the guide catheter via an interface to the hospital hemodynamic monitor. The Navvus catheter interfaces to the RXi system console which includes embedded software, a user interface touch screen and associated electronics.
DEVICE	Pressure Wire	Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-10-16
• Last updated: 2016-12-06

Locations

12 sites across 1 country: United States