Contour Neurovascular System for Brain Aneurysm

(NECC Trial)

Not currently recruiting at 21 trial locations

Overseen By Carin Lindquist

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Cerus Endovascular, Inc.

Must not be taking: Anticoagulants, Anti-platelets

Disqualifiers: Renal failure, Vascular disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of the Contour Neurovascular System for treating certain brain aneurysms, particularly those with a wide neck at a branch point in the brain's blood vessels. The researchers aim to gather data to support an FDA application for device approval. This trial may suit individuals with a single brain aneurysm, whether ruptured or unruptured, requiring treatment. It is especially relevant if the aneurysm has not been treated with other devices and can be managed without additional implants. As a Phase 4 trial, the device has already received FDA approval and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that if you are on anticoagulation medications (like warfarin) that cannot be stopped, you may not be eligible to participate.

What is the safety track record for the Contour Neurovascular System?

Research has shown that the Contour Neurovascular System is generally safe for treating brain aneurysms. In studies, the device was successfully placed in most patients; specifically, out of 34 patients, 32 had successful placements. Many patients experienced good outcomes with few complications. In one study, 44% of patients had their aneurysm completely closed after six months. Another study found low complication rates and positive results during the follow-up period. Overall, evidence suggests the device is well-tolerated, with few side effects reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Contour NEurovasCular System™ is unique because it offers a novel way to treat brain aneurysms using a specialized device designed to target the aneurysm directly. Unlike traditional treatments such as surgical clipping or endovascular coiling, which can be invasive or require complex procedures, this system is designed to be minimally invasive and aims to improve precision in treating the affected area. Researchers are excited about this treatment because it has the potential to reduce recovery time and improve outcomes by focusing directly on stabilizing the aneurysm, potentially offering a safer and more effective alternative.

What evidence suggests that the Contour Neurovascular System is effective for treating brain aneurysms?

Research shows that the Contour Neurovascular System effectively treats wide-necked brain aneurysms. One study found that the device successfully blocked blood flow to over 90% of unruptured aneurysms. Another source confirms the Contour device's safety and effectiveness, particularly for complex aneurysms at brain branch points. The system covers a larger area of the aneurysm opening, contributing to these successful outcomes. Previous studies have demonstrated its high effectiveness and safety. Participants in this trial will be in the "Attempted to Treat" arm, where the investigational device will be used. ^{1 3 4 6 7}

Who Is on the Research Team?

Pascal M Jabbour, MD

Principal Investigator

Jefferson University Hospitals

Demetrius Lopes, MD

Principal Investigator

Advocate Medical Group - Brain and Spine Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with certain wide-necked brain aneurysms sized between 2 and 10.5 mm that require repair, who can follow the study schedule. Excluded are those on non-stop anticoagulants, with severe kidney issues not on dialysis, pregnant or breastfeeding women, participants in other conflicting studies, individuals allergic to device materials or contrast dye, and those with conditions affecting study compliance.

Inclusion Criteria

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

If you have had a burst blood vessel in your brain, you must meet the guidelines from the American Heart Association and American Stroke Association for how it should be managed.

If you have an unruptured brain aneurysm, you need to meet the guidelines from the American Heart Association and American Stroke Association for managing this condition.

Exclusion Criteria

Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device

I have had symptoms or conditions that increase my risk of a stroke in the last 2 months.

I am on blood thinners that I cannot stop taking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Contour NEurovasCular System™ for the treatment of wide-necked bifurcated saccular, intracranial aneurysms

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Contour NEurovasCular System™

Trial Overview The Contour Neurovascular System™ is being tested for its safety and effectiveness in repairing wide-necked bifurcated saccular intracranial aneurysms. The data collected will support a premarket approval application to the FDA.

How Is the Trial Designed?

Group I: Attempted to Treat Experimental Treatment 1 Intervention

Attempted to treat (ATT) with the investigational device

Who Is Running the Clinical Trial?

Cerus Endovascular, Inc.

Lead Sponsor

Trials

7

Recruited

600+

Cerus Endovascular, Ltd

Lead Sponsor

Trials

6

Recruited

350+

Published Research Related to This Trial

The Contour Neurovascular System was successfully implanted in 90% of the 60 intracranial aneurysms treated, showing significant improvement in occlusion rates over time, reaching 89.3% at 1 year.

The device demonstrated a good safety profile with only 3.3% technical complications and no permanent morbidity or mortality, indicating it is a safe option for treating intracranial aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endosaccular flow disruption with the Contour Neurovascular System: angiographic and clinical results in a single-center study of 60 unruptured intracranial aneurysms. Biondi, A., Primikiris, P., Vitale, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014585/

A systematic review of the Contour Neurovascular System ... In unruptured aneurysm, occlusion rate of 91.1% and 93.9% were found. In these studies, the overall re-bleeding or rupture rates were between ...

2. jnis.bmj.com jnis.bmj.com/content/early/2025/01/26/jnis-2024-022517.full.pdf

Contour neurovascular system: have we sufficient clinical ... The three most frequent locations were middle cerebral artery (MCA) in 26.5%, anterior communi- cating artery (Acom) in 26.2%, and basilar tip ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38760167

a multicenter cohort study of 10 European neurovascular ... Here we evaluate the Contour Neurovascular System, an intrasaccular device for the endovascular treatment of cerebral aneurysms, in a multicenter cohort study.

4. sciencedirect.com sciencedirect.com/science/article/pii/S001048252501354X

Larger neck coverage area is associated with longitudinal ... Analysis of the treatment effect of the Contour Neurovascular System in intracranial aneurysms: Larger neck coverage area is associated with longitudinal flow ...

5. journals.lww.com journals.lww.com/neurosurgery/fulltext/2022/03000/the_safety_and_effectiveness_of_the_contour.3.aspx

The Safety and Effectiveness of the Contour Neurovascular... The Contour seems to be both safe and effective in the treatment of intracranial bifurcation aneurysms.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39578062/

Safety and efficacy of the Contour Neurovascular System ... Immediate adequate aneurysm occlusion rate was 53% (95% CI: 1% to 100%), with follow-up adequate occlusion at 93% (95% CI: 88% to 97%) and ...

7. thejns.org thejns.org/view/journals/j-neurosurg/142/1/article-p145.xml

Safety and efficacy of the Contour Neurovascular System for ... There was a low complication rate and good angiographic results at midterm follow-up.