Actively Recruiting
Contour Neurovascular System10 ContiNued Access Investigational Device EXempTion (IDE) Trial
Led by Cerus Endovascular, Inc. · Updated on 2026-03-31
250
Participants Needed
9
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Contour Neurovascular System (CNS) as a treatment for wide-necked, saccular, intracranial aneurysms. This trial aims to collect additional data to assess the safety and effectiveness of the CNS in treating these brain aneurysms. Participants include adults aged 18 to 75 with specific aneurysm characteristics requiring treatment, following guidelines for ruptured or unruptured aneurysms. Participants undergo treatment with the Contour Neurovascular System device during a procedure where its placement is attempted. After treatment, follow-up visits are scheduled at 1 month, 12 months, and 24 months to monitor progress. The study focuses on outcomes such as death or stroke within 30 days, aneurysm occlusion status after one year, and serious adverse events over two years. Throughout the study, participants report any adverse events to the research team and attend scheduled follow-up visits for evaluations. Researchers measure key outcomes including stroke incidence, neurological status, aneurysm closure, and device positioning. The total observation period covers up to two years post-treatment, with careful monitoring to evaluate the device's performance and safety.
CONDITIONS
Brief Title
Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18-75 years of age at the time of screening.
- Patient has a single ruptured or unruptured intracranial aneurysm requiring treatment.
- If additional aneurysms exist, they do not require treatment within 60 days after the procedure.
- Target aneurysm has saccular morphology and is at a bifurcation in anterior or posterior circulation.
- Aneurysm neck diameter between 2 and 10 mm and equatorial diameter between 2 and 10.5 mm.
- Wide-necked aneurysm defined as neck size 64 4 mm or dome/neck ratio less than 2.
- Patient may be treated with Contour without additional implanted devices.
- Patient can comply with all screening, treatment, and follow-up schedules.
- Patient or authorized representative has signed informed consent.
- For unruptured aneurysms, patient meets AHA/ASA management guidelines.
- For ruptured aneurysms, patient meets AHA/ASA subarachnoid hemorrhage guidelines.
- Patient is neurologically stable with Hunt & Hess Score I, II, or III.
You will not qualify if you...
- Anatomy or physiology unsuitable for Contour device treatment.
- Target aneurysm contains other devices that interfere with Contour placement.
- Known untreatable allergy to contrast dye, iodine, or device components.
- Contraindication to anticoagulants or anti-platelet medications.
- Stenosis greater than 50% in the parent vessel.
- Use of anticoagulant medications that cannot be stopped.
- Acute or chronic renal failure (unless on dialysis) or high creatinine levels.
- Vascular disease preventing access to the aneurysm.
- Vasospasm, vasculitis, intracranial tumor (except small meningioma), or vascular malformations.
- High risk for ischemic stroke or recent ischemic symptoms within 60 days.
- Neurological conditions causing unstable symptoms.
- Modified Rankin Scale score 2 or higher before presentation.
- Recent subarachnoid hemorrhage or intracranial hemorrhage within 90 days.
- Conditions preventing compliance with study procedures.
- Pregnant, breastfeeding, or planning pregnancy within 2 years.
- Enrolled in another device or drug study that could affect results.
- Life expectancy less than 2 years due to illness other than the aneurysm.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the procedure to attempt implantation of the Contour Neurovascular System device.
1 procedure visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety and treatment outcomes following the device implantation.
Multiple follow-up visits over 2 years
Trial Site Locations
Total: 9 locations
1
Advocate Aurora Health
Park Ridge, Illinois, United States, 60068
Actively Recruiting
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
3
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14203
Actively Recruiting
4
Stony Brook University
Stony Brook, New York, United States, 11794
Actively Recruiting
5
NC Heart and Vascular Research LLC
Raleigh, North Carolina, United States, 27607
Actively Recruiting
6
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
8
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
9
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Actively Recruiting
Research Team
A
Amelia Saliba
V
Vanessa Sarge
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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