NCT06693011

Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)

Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Cerus Endovascular, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms. Participants will: Undergo treatment with the Contour Neurovascular System Complete follow-up visits at 1month, 12months, and 24 months, following their procedure Report any adverse events to their study team

Conditions

• Cerebral Aneurysms

Interventions

Type	Name	Description
DEVICE	Contour Neurovascular System Treatment Attempt	The subject is brought into the procedure room, an angiogram on the day of the procedure indicates that the subject is anatomically eligible for the trial and any part of the investigational device comes in contact with the patient

Timeline

• Start date: 2025-06-10
• Primary completion: 2028-10-01
• Completion: 2030-01-01
• First posted: 2024-11-18
• Last updated: 2026-03-31

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study