NCT04187573

Coil Assisted Flow Diversion Safety and Performance Study

Coil Assisted Flow Diversion: A Prospective, Single Arm, Multi-center Study to Assess the Safety and Performance of Neqstent in Adjunctive Therapy (CAFI Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Cerus Endovascular, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy. The purpose of the study is to document safety and performance of the Neqstent in adjunctive therapy in treatment for patients with intracranial aneurysms (IA).

Detailed description

Neqstent is designed as an adjunctive therapy for patients with unruptured and failed bifurcation aneurysm embolizations. Neqstent can be positioned at the neck of the aneurysm with or without existing coils and other embolization products. Embolization coils should be added to fill the dome of the aneurysm after placement of Neqstent.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Neqstent	Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.

Timeline

• Start date: 2020-01-21
• Primary completion: 2022-06-17
• Completion: 2023-11-01
• First posted: 2019-12-05
• Last updated: 2024-11-20
• Results posted: 2024-10-23

Locations

7 sites across 5 countries: Austria, Canada, Denmark, Germany, Switzerland

Regulatory

• FDA-regulated device study