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

NCT05079906 | Withdrawn FDA Device

• 1 other identifier: US102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is intended to help establish standard procedures for use of FFR in the peripheral arterial system and to evaluate the correlation of post-procedural FFR values and clinical outcomes in Superficial Femoral artery (SFA) interventions in subjects ages 18 to 79 with PAD.

Conditions

Peripheral Arterial Disease; Superficial Femoral Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Post-PVI FFR

  Explore the correlation of post-PVI FFR values with other established clinical measures (i.e. 6MWT, ABI, VQ-6, WIQ, and arterial duplex US)

  6 months

Study Arms (2)

Main study arm

OTHER

All subjects will have their SFA lesion assessed with FFR measurement.

Device: Fractional Flow Reserve (FFR)

Sub-study

OTHER

Last 50 enrolled subjects will have HD-IVUS in addition to FFR.

Device: Fractional Flow Reserve (FFR); Device: High Definition Intravascular Ultrasound (HD-IVUS)

Interventions

Fractional Flow Reserve (FFR) DEVICE

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.

Main study arm; Sub-study

High Definition Intravascular Ultrasound (HD-IVUS) DEVICE

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.

Sub-study

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-79 at the time of planned SFA intervention
• SFA lesion requires intervention (according to ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention, ABI, imaging, and/or clinical symptoms)
• Index SFA lesion is ≤150 mm
• Rutherford Classification of Peripheral Artery Disease (PAD) is Class 2, 3, 4, or 5
• Minimum two vessel run-off without a hemodynamically significant lesion below the treatment lesion (in at least one vessel to the foot) in the opinion of the treating physician

You may not qualify if:

• Study lesion is a Chronic Total Occlusion (CTO)
• Clinically significant (in the opinion of the treating physician) inflow disease of the aorta, common iliac, external iliac, or common femoral artery
• Presence of an additional hemodynamically significant stenosis within the SFA in the opinion of the treating physician
• Active cancer (any type)
• Life expectancy less than 1 year
• Pregnancy

Sponsors & Collaborators

• Acist Medical Systems: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: May 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share