Research Study: Flo Thru
Condition:
Peripheral arterial disease
Study Sponsor: Acist Medical Systems
Study Investigator: Jesse Manunga, MD
Study Contact: JoAnne Goldman
joanne.goldman@allina.com
612-863-3793
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

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 (Peripheral Arterial Disease).
Eligibility Criteria:

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

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!