Assessment of Superficial Femoral Artery Lesions With FFR From the ACIST Navvus® Catheter

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2022

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2024

Conditions
Peripheral Arterial DiseaseSuperficial Femoral Artery Stenosis
Interventions
DEVICE

Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) for all enrolled subjects. All interventional procedures, including FFR and HD IVUS, will be conducted in accordance with current approved User Guides and Instructions for Use.

DEVICE

High Definition Intravascular Ultrasound (HD-IVUS)

High Definition Intravascular Ultrasound (HD-IVUS) in addition to FFR for last 50 enrolled subjects. All interventional procedures, including FFR and HD IVUS, will be conducted in accordance with current approved User Guides and Instructions for Use.

Sponsors
All Listed Sponsors
lead

Acist Medical Systems

INDUSTRY