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New device aims to seal brain aneurysms without open surgery

NCT ID NCT04852783

Disease control Sponsor: Cerus Endovascular, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called the Contour System to treat brain aneurysms (weak spots in blood vessels that can burst). The device is placed inside the aneurysm to block blood flow and prevent rupture. The trial involves 250 adults aged 18-75 with a specific type of aneurysm. The goal is to see if the device is safe and effective at sealing the aneurysm, reducing the risk of stroke or death.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

250 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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 of 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 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. 9. Patient must be neurologically stable with Hunt \& Hess Score of I, II or III. 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) and/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 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. 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.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm, intracranial

Contacts and locations

Locations

  • Advocate Aurora Health

    Park Ridge, Illinois, 60068, United States

  • Alejandro Spiotta

    Charelston, South Carolina, 29425, United States

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical City Plano

    Plano, Texas, 75075, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NC Heart and Vascular Research LLC

    Raleigh, North Carolina, 27607, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Semmes-Murphy Clinic

    Memphis, Tennessee, 38120, United States

  • Stony Brook Medicine

    Stony Brook, New York, 11794, United States

  • Swedish Medical Center

    Englewood, Colorado, 80113, United States

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122, United States

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UMASS Medical Center

    Worcester, Massachusetts, 01655, United States

  • University at Buffalo Neurosurgery

    Buffalo, New York, 14203, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

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