HORIZON Prospective Clinical Investigation

Status Terminated

Clinical Trial Summary

The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX & PULL in a prospective investigation for the treatment of adult patients with de novo or re-stenotic symptomatic atherosclerotic lesions in Peripheral Artery Disease (PAD) requiring treatment of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment).

Clinical Trial Description

This is a multicenter, prospective study with clinical and radiographic follow-up for 24 months months post-procedure. Approximately two hundred thirty subjects will be enrolled (115 subjects will receive the FLEX type and 115 subjects the PULL type) in several centers, minimum 10 patients per investigational center. All patients will be evaluated at 30 days and 6-, 12- and 24-months post-index procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05234164
Study type	Interventional
Source	Qmedics AG
Contact
Status	Terminated
Phase	N/A
Start date	December 15, 2021
Completion date	November 17, 2023

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