An interventional study of Contour Neurovascular System Treatment Attempt in Cerebral Aneurysms, sponsored by Cerus Endovascular, Inc.. Recruiting at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Cerus Endovascular, Inc. (part of Stryker) · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms.
Participants will:
Undergo treatment with the Contour Neurovascular System Complete follow-up visits at 1month, 12months, and 24 months, following their procedure Report any adverse events to their study team
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Cerus Endovascular, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
First submitted after Cerus Endovascular, Inc. became part of Stryker.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The target IA must have the following characteristics:
Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written prior to initiation of any study procedures.
FOR PATIENTS WITH UNRUPTURED ANEURYSM
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
(\^6: 6 https://www.ahajournals.org/doi/full/10.1161/STR.0000000000000070)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects for which the index procedure (implant of the Contour Neurovascular System) was attempted.
Device: Contour Neurovascular System Treatment Attempt
The subject is brought into the procedure room, an angiogram on the day of the procedure indicates that the subject is anatomically eligible for the trial and any part of the investigational device comes in contact with the patient
Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 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.
Time frame: From enrollment to 1 year
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.
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).
Time frame: From enrollment to 1 year
Incidence of Serious Adverse Events (SAE) associated with the procedure or device
Serious Adverse Events (SAE) associated with the procedure or device, both individually and in aggregate
Time frame: From enrollment to 2 years
Proportions of aneurysm occlusion ratings
·Detailed assessment of aneurysm occlusion from post procedure to one (1) year (and also at two (2) years for any aneurysm not completely occluded at 1 year) provided by the core lab review of the angiogram, including the following: * Complete occlusion (Raymond Roy Scale of 1) * Adequate Occlusion (Raymond Roy Scale of 1 or 2) * Raymond Roy scale 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).
Time frame: From enrollment to 2 years
Incidence of stroke resulting in a disabling deficit
Assessment of incidence of stroke resulting in a disabling deficit, defined operationally as a deficit that, if unchanged, would prevent the patient from performing basic activities of daily living (i.e., bathing, ambulating, toileting, hygiene, and eating) or returning to work (mRS ≥ 3).
Time frame: From enrollment to 2 years
Incidence of serious neurological events
All serious neurological adverse events
Time frame: From enrollment to 2 years
Proportions of device movement ratings
·Detailed assessment of aneurysm occlusion from post procedure to one (1) year (and also at two (2) years for any aneurysm not completely occluded at 1 year) provided by the core lab review of the angiogram, including the following: o Device position (remains in place, migration into the parent artery or movement towards the aneurysm dome)
Time frame: From enrollment to 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Oct 2028, 40 months after the start.
Of 48 industry-sponsored interventional studies with no phase under Intracranial Aneurysm, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 49. This study's planned 40 months is above that.
Counting every sponsor, half of 104 studies reached it within 39 months; a quarter within 22 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.