Actively Recruiting
Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)
Led by Cerus Endovascular, Inc. · Updated on 2026-03-31
250
Participants Needed
9
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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.
- Additional aneurysms requiring treatment must not need treatment within 60 days after the index procedure.
- Target aneurysm has saccular shape.
- Aneurysm is located at a bifurcation in the anterior or posterior circulation.
- Aneurysm neck diameter is between 2 and 10 mm.
- Aneurysm equatorial diameter is between 2 and 10.5 mm.
- Aneurysm is wide-necked, defined as neck size 4 mm or greater or dome/neck ratio less than 2.
- Patient may be treated with Contour without additional implanted devices.
- Patient is able to comply with all screening, evaluation, treatment, and follow-up schedules.
- Patient or legally authorized representative has signed IRB/EC-approved informed consent.
- Patients with unruptured aneurysm meet AHA/ASA guidelines for management.
- Patients with ruptured aneurysm meet AHA/ASA guidelines for management of aneurysmal subarachnoid hemorrhage.
- Patient is neurologically stable with Hunt & Hess Score of I, II, or III.
You will not qualify if you...
- Anatomy or physiology unsuitable for Contour device endovascular treatment.
- Target aneurysm contains other devices or implants that interfere with Contour placement.
- Known untreatable hypersensitivity to contrast dye, iodine, or device components.
- Contraindication to anticoagulants or anti-platelet medications.
- Stenosis of the target aneurysm's parent vessel greater than 50%.
- Use of anticoagulation medications that cannot be discontinued.
- Acute or chronic renal failure unless on dialysis, or creatinine above 2.00 mg/dl.
- Vascular disease or anomaly preventing access to aneurysm for device use.
- Evidence of vasospasm, vasculitis, intracranial tumor (except small meningioma), or other intracranial vascular malformations.
- High risk for ischemic stroke or ischemic symptoms within prior 60 days.
- Conditions causing unstable neurological symptoms (e.g., multiple sclerosis, seizure disorder).
- Modified Rankin Scale score 2 or higher before presentation or rupture.
- Subarachnoid hemorrhage from non-index aneurysm or other intracranial hemorrhage within 90 days.
- Physical, neurologic, or psychiatric conditions preventing compliance with study procedures.
- Pregnant, breastfeeding, or planning pregnancy within 2 years.
- Participation in another 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
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
CONTACT
V
Vanessa Sarge
CONTACT
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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