Intracranial AneurysmNCT02784431

Pilot Study of the Contour Neurovascular SystemTM

A study testing Contour Neurovascular System placement in people with Intracranial Aneurysm, run by Cerus Endovascular, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA) Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intracranial Aneurysm
What is being tested?: Contour Neurovascular System placement
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: Jul 2016to Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80 years at screening
Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
IA appears suitable for Contour Neurovascular SystemTM device Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements Patient able to understand and sign a study-specific informed consent form

Who cannot join

Ruptured IA
Any other IA that requires treatment in the next year
IA width >8.5 or <2 mm
IA neck >8 or <2 mm
IA minimum height <4mm
IA embolisation would most likely cause stroke

Show all 18Show fewer

Target IA contains other devices/implants (e.g., coils)
Inability to access the target IA with the microcatheter
Any congenital or iatrogenic coagulopathy
Platelet count <50,000/microliter
Known allergy to platinum, nickel or titanium
Known allergy to contrast agents
Stenosis of the target IA's parent vessel >50%
Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm
Taking any anticoagulants (e.g., warfarin)
Abnormal clotting parameters
Pregnant, breastfeeding or planning pregnancy in the next 2 years
Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.) or ability to comply with study requirements Participating in another study with investigational devices or drugs

About this study

Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)

Read the detailed description

Prospective, single-arm, multi-centre European study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA). Target aneurysms are unruptured aneurysms requiring endovascular treatment in the anterior and posterior cerebral circulation.

Conditions: Intracranial Aneurysm
Being tested: Contour Neurovascular System placement
Keywords: Brain, Intracranial Aneurysm Treatment, Endovascular Treatment, Brain Aneurysm, Neurovascular diseases, Aneurysms, Cerebrovascular Disorders, Central Nervous System Diseases, Vascular diseases
Medical subject headings: Intracranial Aneurysm, Aneurysm, Cerebrovascular Disorders, Central Nervous System Diseases, Vascular Diseases

What participants receive

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

Contour Neurovascular System placementDevice
Patients who meet the eligibility criteria will have their target aneurysm treated with the Contour Neurovascular System device via standard endovascular procedure.

Study groups in NCT02784431
Study group	Role	What they receive
Contour Neurovascular System placement	Experimental	Treatment of intracranial aneurysm with the Contour Neurovascular System device. Receives: Device: Contour Neurovascular System placement

What is being measured

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

Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.
Percentage of subjects with major ipsilateral stroke/SAH or death due to neurologic cause within six (6) months after treatment. All neurological events were adjudicated by an independent Medical Monitor.
Measured: 6 months

Secondary outcomes (1)

Occlusion Status of the Target IA
Last known occlusion status of the target IA as judged by an independent core laboratory using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm).
Measured: 6 months (3 patients), 1 year (14 patients), 2 year (2 patients)

Timeline

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

Jul 2016Oct 2018

First posted27 May 2016 (estimated)
Study startJul 2016
Primary completionOct 2018
Study completionOct 2018

Why it stopped: To obtain clinical data in EU for CE Mark

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intracranial AneurysmStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02784431
Sponsor's protocol ID: DNX065.A
Status last verified: Jul 2022
First submitted: 20 May 2016
Last updated: 26 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

Official record

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All Intracranial Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of the Contour Neurovascular SystemTM
ClinicalTrials.gov ID: NCT02784431
Acronym / sponsor ID: DNX065.A
Conditions: Intracranial Aneurysm
Keywords: Brain, Intracranial Aneurysm Treatment, Endovascular Treatment, Brain Aneurysm, Neurovascular diseases, Aneurysms, Cerebrovascular Disorders, Central Nervous System Diseases
Study type: Interventional
Recruitment status: TerminatedReason stopped: To obtain clinical data in EU for CE Mark
Enrolment: 20 participants (actual)
Lead sponsor: Cerus Endovascular, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2016
Primary completion: Oct 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 27 May 2016 (estimated)
Results: Posted 23 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Contour Neurovascular System placement	Experimental	Device: Contour Neurovascular System placementTreatment of intracranial aneurysm with the Contour Neurovascular System device.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18-80 years at screening
Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
IA appears suitable for Contour Neurovascular SystemTM device Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements Patient able to understand and sign a study-specific informed consent form

Key exclusion criteria (18 listed)

Ruptured IA
Any other IA that requires treatment in the next year
IA width >8.5 or <2 mm
IA neck >8 or <2 mm
IA minimum height <4mm

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 placementPatients who meet the eligibility criteria will have their target aneurysm treated with the Contour Neurovascular System device via standard endovascular procedure.	Device	Contour Neurovascular System placement

Primary outcome

Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.
Time frame: 6 months
Percentage of subjects with major ipsilateral stroke/SAH or death due to neurologic cause within six (6) months after treatment. All neurological events were adjudicated by an independent Medical Monitor.

1 secondary outcome

Occlusion Status of the Target IA
Time frame: 6 months (3 patients), 1 year (14 patients), 2 year (2 patients)

Results and safety

Results posted to the registry on 23 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated	20	0

Primary outcome: Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Treated n = 19
Value	0

Population analysed: Patients who were successfully implanted with the Contour device.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year (9 patients), 6 months (5 patients), 6 weeks (4 patients), hospital discharge following index procedure (1 patient).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated	4 of 19 (21.1%)	10 of 19 (52.6%)	0 of 19

Limitations and caveats (from the sponsor): The study was terminated early by the Sponsor due to slow enrollment and a change in regulatory strategy. Less than 50% of the planned sample size was enrolled and none of the subjects had been followed for the planned 5 years.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Intracranial Aneurysm

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RecruitingObservational study
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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Contour Neurovascular System placement in people with Intracranial Aneurysm, run by Cerus Endovascular, Inc..

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 3 inclusion and 18 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: stopped early, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment. (time frame: 6 months). 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 NCT02784431.

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 26 Jul 2022.