Peripheral Arterial Disease Clinical Trial
Official title:
Natural Vascular Scaffold (NVS) Therapy for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 3.5 and 7.0 mm and lesion lengths between 36 and 96mm. The system is intended for use in patients with de novo lesions in the superficial femoral and proximal popliteal arteries.
This is a prospective, non-randomized, multi-center, open label Phase 1 study to assess the
safety, pharmacokinetics (PK), and preliminary efficacy trends of applying NVS Therapy to de
novo lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA)
during percutaneous transluminal angioplasty (PTA) in patients with life-style limiting
claudication due to obstructive SFA and proximal popliteal artery atherosclerosis. Each
investigator will receive supervised training for each procedure.
Eligibility to participate in the study is determined during the screening period and prior
to the index procedure. Once a subject has been determined to be suitable for a peripheral
intervention and all general eligibility criteria are met, angiographic eligibility will be
evaluated at the time of the index procedure. Subjects then undergo the procedure with the
NVS Therapy. Study data will be analyzed through the Day 365 follow-up visit.
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