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Contour Neurovascular System for Brain Aneurysm (NECC Trial)
Phase 4
Recruiting
Led By Demetrius Lopes, MD
Research Sponsored by Cerus Endovascular, Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is 18-75 years of age at the time of screening
The target IA must be located at a bifurcation in the anterior or posterior circulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
NECC Trial Summary
This trial is to see if a new device is safe and effective in treating wide-necked bifurcated saccular, intracranial aneurysms.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar devices may cause reactions related to implantation such as bleeding at the site of insertion, infection risk from surgery, possible damage to blood vessels near the aneurysm or stroke-like symptoms if there's interference with normal blood flow.
NECC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
My aneurysm is located where two blood vessels split.
Select...
My brain function is stable with a mild to moderate condition.
Select...
My aneurysm's neck is 2-10 mm wide and its body is 2-10.5 mm wide.
Select...
My aneurysm is at a blood vessel branching point.
NECC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Secondary outcome measures
Key Secondary Effectiveness Endpoint
Key Secondary Safety Endpoint
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Who is running the clinical trial?
Cerus Endovascular, LtdLead Sponsor
5 Previous Clinical Trials
95 Total Patients Enrolled
Demetrius Lopes, MDPrincipal InvestigatorAdvocate Medical Group - Brain and Spine Institute
1 Previous Clinical Trials
140 Total Patients Enrolled
Pascal M Jabbour, MDPrincipal InvestigatorJefferson University Hospitals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I have had symptoms or conditions that increase my risk of a stroke in the last 2 months.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.I am on blood thinners that I cannot stop taking.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.I haven't had a brain bleed from a non-index aneurysm or any other cause in the last 3 months.I cannot have the study device due to my vascular condition.I can be treated with Contour alone, without needing other implants.I have some disability but can walk without assistance.I do not have severe kidney issues or my creatinine is not above 2.00 mg/dl.I have been told I have less than 2 years to live due to a condition other than my brain aneurysm.My aneurysm is located where two blood vessels split.My brain function is stable with a mild to moderate condition.I have one brain aneurysm needing treatment, and if I have another, it doesn't need treatment within 60 days.I have signs of abnormal blood vessels or a brain tumor, except for a small meningioma.The aneurysm being treated must be shaped like a sac.I do not have conditions like MS or seizures that cause unstable symptoms.Your blood vessels are not suitable for treatment with the Contour device, as determined by the doctor and the Patient Selection Committee.The blood vessel leading to the target area is more than 50% blocked.I cannot take blood thinners or medications that prevent blood clots.The aneurysm must be wide-necked, which means the neck size is at least 4 millimeters wide or the ratio of the dome size to the neck size is less than 2.My aneurysm's neck is 2-10 mm wide and its body is 2-10.5 mm wide.I have had a ruptured aneurysm.My aneurysm is at a blood vessel branching point.The shape is like a sac.I have an aneurysm that has not burst.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Intracranial Aneurysms Patient Testimony for trial: Trial Name: NCT04852783 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experimental program open to participants aged 35 or over?
"This study is open to those aged between 18 and 75, with 7 trials available for minors while 151 are allocated specifically to seniors."
Answered by AI
Are there any risks associated with this therapeutic approach?
"As this is a Phase 4 trial, signifying that the treatment has been officially approved, our team at Power have assigned it a safety score of 3."
Answered by AI
How many participants have been admitted to this research endeavor?
"Yes, according to clinicaltrials.gov, this trial is currently enrolling patients. It was first posted on August 6th 2021 and edited most recently on November 8th 2022. This experiment necessitates the recruitment of 220 individuals at 18 different sites."
Answered by AI
Is there a way I can participate in this clinical research?
"The selection criteria for this trial necessitates that participants have aneurysm and be between the ages of 18 to 75. A maximum of 220 volunteers are permitted in the study."
Answered by AI
How many locations are carrying out this experiment?
"This trial has been initiated out of 21 medical centres, including Westchester Medical Center in Valhalla, New york; NC Heart and Vascular Research LLC in Raleigh, North carolina; and Swedish Neuroscience Institute in Seattle, Washington."
Answered by AI
Can new participants still join this experiment?
"Clinicaltrials.gov indicates that this medical trial is actively looking for candidates, with the first post dated August 6th 2021 and most recent update on November 8th 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I had a vessel that burst last year and made me paralyzed on my left side.
PatientReceived no prior treatments
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