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 — CHAMPIONSHIP

Superficial Femoral Artery Stenosis Clinical Trial

Official title:
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

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Constriction, Pathologic
Popliteal Artery Stenosis
Superficial Femoral Artery Stenosis

Clinical Trial Details

NCT number	NCT06410313
Study type	Interventional
Source	Medinol Ltd.
Contact	Brenda Koltun Reuven
Phone	+972542666688
Email	brendak@medinol.com
Status	Not yet recruiting
Phase	N/A
Start date	July 15, 2024
Completion date	February 28, 2028

View Details

See also
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