Aneurysm, IntracranialPhase 4NECCNCT04852783

US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

A Phase 4 study testing Contour Neurovascular System in people with Aneurysm, Intracranial, run by Cerus Endovascular, Inc. at 20 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Aneurysm, Intracranial
What is being tested?: Contour Neurovascular System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 20 sitesUnited States
Study dates: 6 Aug 2021to Feb 2030
Phase: Phase 4
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 of 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

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

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

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Acute / chronic renal failure (unless on dialysis) and/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 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).
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

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
University at Buffalo Neurosurgery
Buffalo, New York, 14203
Alejandro Spiotta
Charelston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Swedish Medical Center
Englewood, Colorado, 80113
Baptist Health
Jacksonville, Florida, 32207
University of Kansas Medical Center
Kansas City, Kansas, 66160
Semmes-Murphy Clinic
Memphis, Tennessee, 38120
NYU Langone Health
New York, New York, 10016
Advocate Aurora Health
Park Ridge, Illinois, 60068
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Medical City Plano
Plano, Texas, 75075
NC Heart and Vascular Research LLC
Raleigh, North Carolina, 27607
Swedish Neuroscience Institute
Seattle, Washington, 98122
Stony Brook Medicine
Stony Brook, New York, 11794
Montefiore Medical Center
The Bronx, New York, 10467
Westchester Medical Center
Valhalla, New York, 10595
UMASS Medical Center
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Read the detailed description

Conditions: Aneurysm, Intracranial
Being tested: Contour Neurovascular System
Medical subject headings: Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Contour Neurovascular SystemDevice
Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.

Study groups in NCT04852783
Study group	Role	What they receive
Attempted to Treat	Experimental	Attempted to treat (ATT) with the investigational device Receives: Device: Contour Neurovascular System

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Safety Endpoint: 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.
Measured: 30 days
Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.
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.
Measured: 1 year

Secondary outcomes (2)

Key Secondary Effectiveness Endpoint
The trial's secondary endpoint is the proportion of subjects with angiographic aneurysmal recurrence defined as aneurysm growth or recanalization at one (1) year after treatment.
Measured: 1 year
Key Secondary Safety Endpoint
Proportion of subjects with death of any non-accidental cause or any major stroke (an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the NIHSS as of day 7 post onset) within the first 30-days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 after treatment.
A major stroke is "a stroke, which increased the NIHSS by ≥ 4 at the time of assessment and which remained present after 7 days"
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 2021Feb 2030

First posted21 Apr 2021
Study start6 Aug 2021
Primary completion20 Feb 2026
Study completionFeb 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aneurysm, IntracranialStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This trial is a prospective, multicenter single-arm study.
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04852783
Sponsor's protocol ID: DNX102-01
Acronym: NECC
Status last verified: Mar 2026
First submitted: 16 Apr 2021
Last updated: 31 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain

All Aneurysm, Intracranial trials

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: US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
ClinicalTrials.gov ID: NCT04852783
Acronym / sponsor ID: NECC / DNX102-01
Conditions: Aneurysm, Intracranial
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 250 participants (actual)
Lead sponsor: Cerus Endovascular, Inc.Industry (pharma, biotech, devices)
Study start: 6 Aug 2021 (actual)
Primary completion: 20 Feb 2026 (actual)
Study completion: Feb 2030 (estimated)
First posted: 21 Apr 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This trial is a prospective, multicenter single-arm study.

Arm	Type	Receives
Attempted to Treat	Experimental	Device: Contour Neurovascular SystemAttempted to treat (ATT) with the investigational device

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 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 of 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 SystemEndovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.	Device	Attempted to Treat

Primary outcome

Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Time frame: 30 days
Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.
Time frame: 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.

2 secondary outcomes

Key Secondary Effectiveness Endpoint
Time frame: 1 year
Key Secondary Safety Endpoint
Time frame: 1 year

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

Related trials for Aneurysm, Intracranial

Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
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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. This study is not recruiting at the moment.

Pascal M Jabbour, MD principal investigator

Jefferson University Hospitals

Demetrius Lopes, MD principal investigator

Advocate Medical Group - Brain and Spine Institute

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Contour Neurovascular System in people with Aneurysm, Intracranial, run by Cerus Endovascular, Inc. at 20 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 14 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: under way, not looking for participants, 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 20 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year. (time frame: 30 days). 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?

On the ClinicalTrials.gov record for NCT04852783.

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.