Intracranial AneurysmNCT04579081
Post Market Clinical Follow-up (PMCF)Study of the Contour Neurovascular SystemTM
An observational study of Intracranial Aneurysm, run by Cerus Endovascular, Inc..
Trial summary
Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Contour Neurovascular System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with enraptured bifurcated intracranial aneurysms.
Who may be able to join
- 1. Patient indicated for treatment of a single, unruptured aneurysm is according to the national/international guidelines.
- 2. Age 18 years or older at screening. 3. Patient suitable for non-emergency endovascular embolization of saccular IAs.
- 4. IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU for Contour.
- 5. 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.
- 6. Patient is able to give their informed consent. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.
Who cannot join
- Ruptured aneurysm.
- Patient anatomy or physiology considered unsuitable for endovascular treatment.
- Contraindication for arterial access.
- Largest measured IA equatorial diameter >8.5 mm or <2 mm.
- Largest measured IA neck diameter >8 mm or <2 mm.
- Target IA contains other devices/implants that could interfere with proper placement of the Contour device (e.g., coils).
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- Known allergy to platinum, nickel or titanium.
- Known allergy or intolerance to contrast agents.
- Contraindication to anticoagulants or platelet inhibitor medication.
- In the opinion of the investigator, any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc.
- Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, substance abuse and hematologic disorders etc.).
- Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes.
- The presence of a condition that may create unacceptable risk during the aneurysm embolization procedure.
- Female patient who is pregnant or breastfeeding.
About this study
Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use.
Read the detailed description
The primary objective of this study is to document the safety and performance of the "Contour Neurovascular System™. The data from the study will be reported as a Post Market study to the Notified Body as part of the Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plan.
- Conditions
- Intracranial Aneurysm
- 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
Intrasaccular flow disruptor/divertor
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with non-accidental death cause or any major ipsilateral stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurological cause from day 31 to final follow-up visit per standard of care).
Primary Safety Endpoint
Measured: 1 year
Aneurysm occlusion rate on the follow-up angiogram as reported by the investigator." "Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy (RR) Scale.
Primary Performance Endpoint
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: This study has not been started. The Sponsor has decided not to pursue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Endovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579081
- Sponsor's protocol ID
- DNX090-03
- Status last verified
- Mar 2022
- First submitted
- 1 Oct 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up (PMCF)Study of the Contour Neurovascular SystemTM
- ClinicalTrials.gov ID
- NCT04579081
- Acronym / sponsor ID
- DNX090-03
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study has not been started. The Sponsor has decided not to pursue this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cerus Endovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 8 Oct 2020 (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.
Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use.
Detailed description
The primary objective of this study is to document the safety and performance of the "Contour Neurovascular System™. The data from the study will be reported as a Post Market study to the Notified Body as part of the Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plan.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with enraptured bifurcated intracranial aneurysms.
Key inclusion criteria (5 listed)
- 1. Patient indicated for treatment of a single, unruptured aneurysm is according to the national/international guidelines.
- 2. Age 18 years or older at screening. 3. Patient suitable for non-emergency endovascular embolization of saccular IAs.
- 4. IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU for Contour.
- 5. 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.
- 6. Patient is able to give their informed consent. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.
Key exclusion criteria (14 listed)
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 SystemIntrasaccular flow disruptor/divertor | Device | – |
Primary outcome
The proportion of subjects with non-accidental death cause or any major ipsilateral stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurological cause from day 31 to final follow-up visit per standard of care).
Time frame: 1 year
Primary Safety Endpoint
Aneurysm occlusion rate on the follow-up angiogram as reported by the investigator." "Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy (RR) Scale.
Time frame: 1 year
Primary Performance Endpoint
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- 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. 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?
An observational study of 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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 22 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The proportion of subjects with non-accidental death cause or any major ipsilateral stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurological cause from day 31 to final follow-up visit per standard of care). (time frame: 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 22 Mar 2022.