First In Human Study to Assess Safety and Efficacy of the ChampioNIR Drug Eluting Peripheral Stent in the Treatment of Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease (NCT06410313)

Peripheral arterial disease (PAD) is a condition which leads to narrowing and blockages in the large and medium-sized arteries which supply blood to your leg which typicalling requires angioplasty treatment. The ChampioNIR DES is a stent made of metal, coated with a mesh that can expand and which contains a drug called ridaforolimus. . Ridaforolimus stops cells from growing and replicating by attaching to a protein called mTOR, meaning that cells are less likely to build up around your stent and narrow your arteries.

Trial phase

Pilot

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

Prof Gerard Goh

Key inclusion data

Inclusion: Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80. Exclusion: Receiving dialysis or immunosuppressant therapy within the previous 30 days; Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.