This is a prospective, open label, multicenter, single arm, first in human clinical study.
Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound
Age ≥ 18 years and of age of legal consent.
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.
A single superficial femoral artery lesion with >50% stenosis or total occlusion.
Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.
Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion either within the same procedure or at least 30 days prior to the index procedure.
Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
Single group
ChampioNIR Ridaforolimus Eluting Peripheral Stent System
DeviceChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease
Primary patency of the target lesion
Primary patency of the target lesion defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) ≥2.4).
Primary safety endpoint
Composite rate of freedom from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation
Primary patency
Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR ≥2.4)
Acute device success
Acute device success, defined as achievement of a final residual diameter stenosis of \<30% by Quantitative Angiography (QA), using the assigned treatment only
Acute procedural success
Acute procedural success, defined as device success with \<30% residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient \<5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay
Acute technical success
Acute technical success, defined as the attainment of \<30% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory
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