NCT04305626

Coated Mongolian Aneurysm Treatment Study 1

Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Phenox GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.

Detailed description

Title: Observational Registry With p64 MW HPC and p48 MW HPC in Unruptured Anterior Circulation Aneurysms Under Dual Antiplatelet Medication. Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under Dual Antiplatelet Medication in consecutive patients with unruptured anterior circulation aneurysms. Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.

Conditions

• Intracranial Aneurysm
• Aneurysm
• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	Endovascular treatment of intracranial aneurysms	Endovascular treatment of intracranial aneurysms with flow diversion.

Timeline

• Start date: 2019-06-22
• Primary completion: 2023-06-22
• Completion: 2023-12-30
• First posted: 2020-03-12
• Last updated: 2022-04-26

Locations

1 site across 1 country: Mongolia