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Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

NCT03680742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-06-23

Study results available
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Summary

Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour").

The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

Contour Neurovascular System

The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.

Sponsors & Collaborators

  • Cerus Endovascular, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Liebig, MD · Ludwig-Maximilians - University of Munich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2020-08-10
Completion
2021-02-02

Countries

  • Austria
  • Denmark
  • Germany

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 NCT03680742 on ClinicalTrials.gov