Continued access to the Contour Neurovascular System for treating wide‑neck bifurcation cerebral aneurysms.

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cerus Endovascular, Inc. (industry)
• Locations: 9 sites (Park Ridge, Illinois and 8 other locations)
• Trial ID: NCT06693011 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Park Ridge, Illinois and 8 other locations

• 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)
• 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

Conditions: Cerebral Aneurysms, aneurysm, wide-neck, bifurcated, saccular