Assessment of Superficial Femoral Artery Lesions With FFR From the ACIST NavvusĀ® Catheter (NCT05079906) | Clinical Trial Compass
WithdrawnNot Applicable
Assessment of Superficial Femoral Artery Lesions With FFR From the ACIST NavvusĀ® 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Stopped: Withdrawn due to timing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 range18 Years ā 79 Years
SexALL
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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 ā¤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