Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)
NCT06693011 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-03-31
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
- 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
Sponsors & Collaborators
-
Cerus Endovascular, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-10
- Primary Completion
- 2028-10-31
- Completion
- 2030-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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