WithdrawnNot Applicable

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

Stopped: Withdrawn due to timing

0Started 2022-05

Plain-language 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.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-PVI FFR

Timeframe: 6 months

Trial details

NCT IDNCT05079906

SponsorAcist Medical Systems

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06

View on ClinicalTrials.gov More Peripheral Arterial Disease trials

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.