Cerebral AneurysmsNEXTNCT06693011
Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)
A study testing Contour Neurovascular System Treatment Attempt in people with Cerebral Aneurysms, run by Cerus Endovascular, Inc. at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Aneurysms
- What is being tested?
- Contour Neurovascular System Treatment Attempt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Jun 2025to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18-75 years of age at the time of screening.
- 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.
- 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
Show all 16Show fewer
- Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio < 2
- Patient may be treated with Contour without the use of additional implanted devices.
- Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
- 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
- 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
- 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
- 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)
Who cannot join
- Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
- Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
- Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
- Contraindication to anticoagulants or anti-platelet medications
- Stenosis of the target IA's parent vessel is >50%
- Anticoagulation medications (e.g., warfarin) that cannot be discontinued
Show all 17Show fewer
- Acute / chronic renal failure (unless on dialysis) or creatinine > 2.00 mg/dl or > 182 μmol/L
- Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
- Clinical, angiographic or computed tomography (CT) evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
- 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.
- Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder).
- Modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable).
- Subarachnoid hemorrhage (SAH) from a non-index aneurysm or any other intracranial hemorrhage within 90 days.
- 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.
- Pregnant, breastfeeding or planning pregnancy in the next 2 years
- Subject is enrolled in another device or drug study in which participation could confound study results.
- Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University at Buffalo Neurosurgery
Buffalo, New York, 14203
Ellen Carl, 716-472-9560, ecarl@ubns.com
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Melza Goffinet, 843-792-1679, vanroije@musc.edu
Alejandro Spiotta, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jason Gorup, 913-588-6122, jgorup@kumc.edu
Koji Ebersole, MD
- Recruiting
Advocate Aurora Health
Park Ridge, Illinois, 60068
Gina Littlejohn, 847-723-2099, Gina.Littlejohn@aah.org
Demetrius Lopes, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Leah Coghlan, 215-341-5864, leah.coghlan@pennmedicine.upenn.edu
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Danna Smith, 215-955-2173, Danna.Smith@jefferson.edu
Pascal Jabbour, MD
- Recruiting
NC Heart and Vascular Research LLC
Raleigh, North Carolina, 27607
Jennifer Vanduine, 919-784-3100, jennifer.vanduine@unchealth.unc.edu
Tibor Beckse, MD
- Recruiting
Swedish Neuroscience Institute
Seattle, Washington, 98122
Laura Johnson, 206- 320-2800
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
Marlene Baumeister, 631-444-1213
About this study
Official title: Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial
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
- Conditions
- Cerebral Aneurysms
- Being tested
- Contour Neurovascular System Treatment Attempt
- Keywords
- aneurysm, wide-neck, bifurcated, saccular
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contour Neurovascular System Treatment AttemptDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment Attempt with the Contour Neurovascular System | Experimental | Subjects for which the index procedure (implant of the Contour Neurovascular System) was attempted. Receives: Device: Contour Neurovascular System Treatment Attempt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From enrollment to 1 year
Secondary outcomes (5)
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
Measured: 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).
Measured: 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).
Measured: From enrollment to 2 years
Incidence of serious neurological events
All serious neurological adverse events
Measured: 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:
- Device position (remains in place, migration into the parent artery or movement towards the aneurysm dome)
Measured: From enrollment to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start10 Jun 2025
- Primary completionOct 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, multicenter, single-arm study.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerus Endovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693011
- Sponsor's protocol ID
- DNX140-01
- Acronym
- NEXT
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial
- ClinicalTrials.gov ID
- NCT06693011
- Acronym / sponsor ID
- NEXT / DNX140-01
- Conditions
- Cerebral Aneurysms
- Keywords
- aneurysm, wide-neck, bifurcated, saccular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cerus Endovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, multicenter, single-arm study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Attempt with the Contour Neurovascular System | Experimental | Device: Contour Neurovascular System Treatment AttemptSubjects for which the index procedure (implant of the Contour Neurovascular System) was attempted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient is 18-75 years of age at the time of screening.
- 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.
- The target IA must have the following characteristics:
- Patient may be treated with Contour without the use of additional implanted devices.
- Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
Key exclusion criteria (17 listed)
- Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
- Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
- Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
- Contraindication to anticoagulants or anti-platelet medications
- Stenosis of the target IA's parent vessel is >50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contour Neurovascular System Treatment AttemptThe 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 | Device | Treatment Attempt with the Contour Neurovascular System |
Primary outcome
Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Time frame: 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.
Time frame: 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).
5 secondary outcomes
Incidence of Serious Adverse Events (SAE) associated with the procedure or device
Time frame: From enrollment to 2 years
Proportions of aneurysm occlusion ratings
Time frame: From enrollment to 2 years
Incidence of stroke resulting in a disabling deficit
Time frame: From enrollment to 2 years
Incidence of serious neurological events
Time frame: From enrollment to 2 years
Proportions of device movement ratings
Time frame: From enrollment to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contour Neurovascular System Treatment Attempt in people with Cerebral Aneurysms, run by Cerus Endovascular, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelia Saliba (408-582-4552, amelia.saliba@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year. (time frame: From enrollment to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.