Continued access to the Contour Neurovascular System for treating wide‑neck bifurcation cerebral aneurysms.
Official title: Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial
Run by Cerus Endovascular, Inc. · NCT06693011 · Data updated 2026-11-12
This program will try the Contour Neurovascular System in adults with wide‑neck, bifurcation saccular brain aneurysms to see if it is safe and effective.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Cerus Endovascular, Inc. Industry-sponsored |
| Locations | 9 sites (Park Ridge, Illinois and 8 other locations) |
| Status | Recruiting |
| Started | June 10, 2025 |
| Main results expected | October 2028 |
| Study ends | January 2030 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT06693011 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with a single saccular bifurcation intracranial aneurysm meeting the specified neck and size criteria, ruptured or unruptured, who can undergo endovascular treatment and complete follow‑up are ideal candidates.
✕Probably not a fit
Patients with non‑saccular or non‑bifurcation aneurysms, aneurysm dimensions outside the specified ranges, those requiring additional implanted devices, or those unable to complete follow‑up are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Contour Neurovascular System (CNS) is an intrasaccular device placed endovascularly to occlude wide‑neck, saccular aneurysms at arterial bifurcations. Eligible adults undergo device placement and return for imaging and clinical follow‑up at 1, 12, and 24 months to document aneurysm occlusion and any adverse events. Enrollment is limited to patients with a single ruptured or unruptured bifurcation aneurysm that meets specified neck and size criteria and who can be treated without additional implanted devices. Data collection focuses on expanding safety and effectiveness information to support continued patient access to the device.
Why it matters
Potential benefit: If successful, this could provide a durable, single‑device option to seal wide‑neck bifurcation aneurysms and potentially reduce the need for multiple implants or retreatment.
How similar studies have gone: Prior case series and early clinical experience with the Contour device and similar intrasaccular flow‑disruption devices have shown promising aneurysm occlusion rates and acceptable safety, though larger controlled data are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient is 18-75 years of age at the time of screening. 2. Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days after the index procedure. 3. The target IA must have the following characteristics: * Saccular morphology * Located at a bifurcation in the anterior or posterior circulation * Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm * Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio \< 2 4. Patient may be treated with Contour without the use of additional implanted devices. 5. Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. 6. Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written informed consent prior to initiation of any study procedures. FOR PATIENTS WITH UNRUPTURED ANEURYSM 7. Patient meets the criteria outlined in the "Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms" as published by the AHA/ASA\^6 FOR PATIENTS WITH RUPTURED ANEURYSM 8. Patient meets the criteria outlined in the "Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association" as published by the AHA/ASA.\^6 9. Patient must be neurologically stable with Hunt \& Hess Score of I, II or III. (\^6: 6 https://www.ahajournals.org/doi/full/10.1161/STR.0000000000000070) Exclusion Criteria: 1. Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee 2. Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device 3. Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device. 4. Contraindication to anticoagulants or anti-platelet medications 5. Stenosis of the target IA's parent vessel is \>50% 6. Anticoagulation medications (e.g., warfarin) that cannot be discontinued 7. Acute / chronic renal failure (unless on dialysis) or creatinine \> 2.00 mg/dl or \> 182 μmol/L 8. Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device. 9. Clinical, angiographic or computed tomography (CT) evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation. 10. Conditions placing them at high risk for ischemic stroke or had exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60-days. 11. Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder). 12. Modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable). 13. Subarachnoid hemorrhage (SAH) from a non-index aneurysm or any other intracranial hemorrhage within 90 days. 14. Physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. 15. Pregnant, breastfeeding or planning pregnancy in the next 2 years 16. Subject is enrolled in another device or drug study in which participation could confound study results. 17. Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm.
Where it's running
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Advocate Aurora Health
Park Ridge, Illinois, United States Recruiting -
University of Kansas Medical Center
Kansas City, Kansas, United States Recruiting -
University at Buffalo Neurosurgery
Buffalo, New York, United States Recruiting -
Stony Brook University
Stony Brook, New York, United States Recruiting -
NC Heart and Vascular Research LLC
Raleigh, North Carolina, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Show 3 more locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States Recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting -
Swedish Neuroscience Institute
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Amelia Saliba
- Email: amelia.saliba@stryker.com
- Phone: 408-582-4552
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.