Intracranial AneurysmINCANCT02507531
INCA: Intracranial Aneurysm Treatment With NeXsys
A study testing NeXsys Embolization System in people with Intracranial Aneurysm, run by Cerus Endovascular, Inc. at 1 site in Argentina.
Trial summary
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion 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?
- NeXsys Embolization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteArgentina
- Study dates
- May 2016to 8 Jan 2019
- Phase
- Interventional
- 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 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 NeXsys device
- Patient willing 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 >10 mm
- IA neck >9 mm
- IA has important flow from its base such that occluding the IA would cause stroke
- Target IA contains any device (e.g., coils)
Show all 17Show fewer
- Inability to access the target IA with 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)
- Taking any anticoagulants (e.g., warfarin)
- Pregnant 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.)
- Participating in another study with investigational devices or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion
Read the detailed description
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion. Target aneurysms are small unruptured aneurysms in the anterior and posterior circulation.
- Conditions
- Intracranial Aneurysm
- Being tested
- NeXsys Embolization 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.
NeXsys Embolization SystemDevice
Also called Contour Neurovascular System
Woven metallic mesh placed in aneurysm fundus
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Placement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure. Receives: Device: NeXsys Embolization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: occurrence of major ipsilateral stroke or neurologic death
Measured: 3-6 months
Ability of the investigator to place the device in an acceptable position in the target IA, judged at the time of placement, with no migration or change in position of the device at 3-6 month angiogram.
Measured: 3-6 mo
Secondary outcomes (2)
Occlusion status of the target IA at 30 days, 3-6 months, 1 year and 5 years as judged by an independent physician using the Raymond classification system.
Measured: 30 days, 3-6 months, 1 year and 5 years
Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure
Measured: Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startMay 2016
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Why it stopped: Poor enrollment
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT02507531
- Sponsor's protocol ID
- DNX-041
- Acronym
- INCA
- Status last verified
- May 2016
- First submitted
- 20 Jul 2015
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCA: Intracranial Aneurysm Treatment With NeXsys
- ClinicalTrials.gov ID
- NCT02507531
- Acronym / sponsor ID
- INCA / DNX-041
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cerus Endovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 24 Jul 2015 (estimated)
- 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.
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion
Detailed description
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion. Target aneurysms are small unruptured aneurysms in the anterior and posterior circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: NeXsys Embolization SystemPlacement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 NeXsys device
- Patient willing to comply with study requirements
- Patient able to understand and sign a study-specific informed consent form
Key exclusion criteria (17 listed)
- Ruptured IA
- Any other IA that requires treatment in the next year
- IA width >10 mm
- IA neck >9 mm
- IA has important flow from its base such that occluding the IA would cause stroke
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 |
|---|---|---|
| NeXsys Embolization SystemAlso: Contour Neurovascular SystemWoven metallic mesh placed in aneurysm fundus | Device | Treatment |
Primary outcome
Safety: occurrence of major ipsilateral stroke or neurologic death
Time frame: 3-6 months
Ability of the investigator to place the device in an acceptable position in the target IA, judged at the time of placement, with no migration or change in position of the device at 3-6 month angiogram.
Time frame: 3-6 mo
2 secondary outcomes
Occlusion status of the target IA at 30 days, 3-6 months, 1 year and 5 years as judged by an independent physician using the Raymond classification system.
Time frame: 30 days, 3-6 months, 1 year and 5 years
Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure
Time frame: Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours)
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeXsys Embolization System in people with Intracranial Aneurysm, run by Cerus Endovascular, Inc. at 1 site in Argentina.
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 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: stopped early, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
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?
Safety: occurrence of major ipsilateral stroke or neurologic death (time frame: 3-6 months). 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 31 Jan 2019.