New device aims to seal brain aneurysms without surgery
NCT ID NCT06693011
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This clinical trial is testing a device called the Contour Neurovascular System for people with wide-necked brain aneurysms. The device is placed inside the aneurysm to block blood flow and prevent it from rupturing. The study will enroll 250 participants and follow them for two years to see if the treatment is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Contour Neurovascular System (a device placed inside the aneurysm to block blood flow)
- What this could lead to
- If successful, this device could offer a safe and effective way to treat wide-necked brain aneurysms without open surgery, reducing the risk of rupture or stroke.
- What could go wrong
- This is an ongoing study with no results yet. The device may not work for all aneurysm shapes, and risks include stroke, bleeding, or the need for additional treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advocate Aurora Health
RECRUITINGPark Ridge, Illinois, 60068, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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NC Heart and Vascular Research LLC
RECRUITINGRaleigh, North Carolina, 27607, United States
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Stony Brook University
RECRUITINGStony Brook, New York, 11794, United States
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Swedish Neuroscience Institute
RECRUITINGSeattle, Washington, 98122, United States
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Thomas Jefferson University
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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University at Buffalo Neurosurgery
RECRUITINGBuffalo, New York, 14203, United States
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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