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

NCT02317081 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-06-29

No results posted yet for this study

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.

Conditions

  • Native Coronary Artery Stenosis

Interventions

DEVICE

Axetis Inert Coronary Stents

de novo coronary artery stenosis in native vessels

Sponsors & Collaborators

  • Axetis AG

    lead INDUSTRY

Principal Investigators

  • Yvonne Teunissen, PhD · Cardialysis BV

  • Mariann Gyöngyösi, Prof. MD · University Hospital, Cardiology, Vienna, Austria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-12-31
Completion
2017-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02317081 on ClinicalTrials.gov