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Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

NCT04870047 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2025-06-04

No results posted yet for this study

Summary

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.

Sponsors & Collaborators

  • Phenox GmbH

    lead INDUSTRY

Principal Investigators

  • Laurent Pierot, Prof. Dr. · CHRU Hôpital Maison-Blanche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2024-12-04
Completion
2025-12-31

Countries

  • France
  • Germany
  • Israel
  • Italy
  • Slovakia
  • Switzerland
  • United Kingdom

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 NCT04870047 on ClinicalTrials.gov