NCT02317081

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Axetis AG · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Native Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Axetis Inert Coronary Stents	de novo coronary artery stenosis in native vessels

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-12-01
• Completion: 2017-07-01
• First posted: 2014-12-15
• Last updated: 2015-06-29

Locations

3 sites across 1 country: Netherlands