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Contour Neurovascular System for Cerebral Aneurysms (NEXT Trial)

This study is looking into the Contour Neurovascular System™ as a treatment for cerebral aneurysms (weak, bulging spots in a blood vessel in the brain). The goal is to see if this system is a safe and effective way to treat wide-necked, saccular (sac-like) aneurysms. You could be eligible if you are between 18 and 75 years old and have a single aneurysm that needs treatment. The study will measure success by looking at serious events like death or stroke within 30 days of treatment, or within one year. It will also check if the aneurysm is completely closed by the Contour system after one year without needing more treatment or causing other problems. The current status of this study is unclear, and it plans to enroll 250 participants.

Study design
This is an interventional study that plans to enroll 250 participants. It is testing the Contour Neurovascular System™ as a treatment.
What's involved
You would undergo treatment with the Contour Neurovascular System and complete follow-up visits at 1 month, 12 months, and 24 months after the procedure. You would also report any side effects to the study team.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months after treatment, with primary outcomes measured at one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06693011

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

Recruiting
NAAges 18–75InterventionalTreatment
Cerus Endovascular, Inc.
~250 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Contour Neurovascular System Treatment Attempt

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Measured over From enrollment to 1 year
+1 more outcome measured

Conditions

Cerebral Aneurysms

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Cerebral Aneurysm

NCT06693011

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advocate Aurora Health

    Park Ridge, Illinoisstudy coordinator listed

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolinastudy coordinator listed

    Recruiting

  • NC Heart and Vascular Research LLC

    Raleigh, North Carolinastudy coordinator listed

    Recruiting

  • Stony Brook University

    Stony Brook, New Yorkstudy coordinator listed

    Recruiting

  • Swedish Neuroscience Institute

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • University at Buffalo Neurosurgery

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Amelia Saliba
[email protected]
408-582-4552
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.From enrollment to 1 year

    Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year. Stroke is defined per the World Health Organization as: rapidly developing clinical signs of focal or global disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke.

  • Proportion of complete occlusion of the aneurysm with Contour, without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment.From enrollment to 1 year

    Complete occlusion of the aneurysm with Contour as defined by complete aneurysm occlusion (Raymond Roy Scale of 1) without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis (\> 50% stenosis) at one (1) year after treatment as assessed by the angiographic core laboratory. The Raymond-Roy Scale grades aneurysms on a scale of one (1) to three (3) with a lower score correlating with a more favorable outcome. The Raymond-Roy Scale will be graded in accordance with the following definitions: Class 1 (Complete obliteration of the aneurysm), Class 2 (Persistence of any portion of the original defect of the arterial wall as seen on any single projection but without opacification of the aneurysmal sac), or Class 3 (Any opacification of the aneurysmal sac).