Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)

Native Coronary Artery Stenosis Clinical Trial

Official title: Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)

Status Recruiting

Clinical Trial Summary

Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.

Clinical Trial Description

Prospective, multicenter, open-label and single arm study, conducted in 3 interventional cardiology centers in The Netherlands. The objective is to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels. In total, 35 patients will be enrolled. All patients will be treated with Axetis Inert Coronary Stent System. All patients will undergo repeat angiography at 6 months follow-up. Quantitative coronary angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and at 6 months follow-up. All patients will undergo Optical coherence Tomography (OCT) investigation at baseline (post procedure) and at 6 months follow-up. The primary endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. Clinical follow-up will occur at 6 and 12 months post-stent implantation. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Stenosis
• Native Coronary Artery Stenosis

• NCT number: NCT02317081
• Study type: Interventional
• Source: Axetis AG
• Contact: Silvio Schaffner
• Email: axetis@gmx.ch
• Status: Recruiting
• Phase: N/A
• Start date: February 2014
• Completion date: July 2017