Peripheral Arterial Disease Clinical Trial
— FLO THRUOfficial title:
Assessment of Superficial Femoral Artery Lesions With FFR From the ACIST Navvus® Catheter
NCT number | NCT05079906 |
Other study ID # | US102 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2022 |
Est. completion date | June 2024 |
Verified date | October 2022 |
Source | Acist Medical Systems |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Acist Medical Systems |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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