Peripheral Arterial Disease Clinical Trial
Official title:
A Single-Arm, Multicenter Study for the Lower Extremities Using the Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection
The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with follow-up to 30 days to determine the acute safety, acute device performance and clinical performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries.
The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with
follow-up to 30 days to determine the acute safety, acute device performance and clinical
performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic
Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic
Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA)
and capture and removal of embolic material during angioplasty for the femoral, iliac,
popliteal and profunda arteries.
The Vanguard System has been designed to revascularize iliac and femoro-popliteal PAD while
protecting against embolization at the same time. It is the first system in which the embolic
protection filter is coupled on the same catheter as the angioplasty balloon for use in the
lower extremities. Up to 130 patients will be enrolled into this study and followed for 30
days after post-procedure. Adult patients with lifestyle-limiting claudication or rest pain
(Rutherford categories 2 to 3) who meet all eligibility criteria will be approached for
participation in the trial.
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