Intracranial AneurysmsNCT01054391
Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae
A study testing NEC - Neurovascular Embolization Cover in people with Intracranial Aneurysms and Cavernous Carotid Fistula, run by Nfocus Neuromedical at 2 sites in Germany.
Trial summary
The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Intracranial Aneurysms, Cavernous Carotid Fistula, Vertebrobasilar Fistula
- What is being tested?
- NEC - Neurovascular Embolization Cover
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2008to Dec 2010
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of unruptured aneurysm OR ruptured aneurysm in clinically stable patients in whom coils alone are not an efficient treatment in the opinion of the investigator (i.e., large neck or fusiform aneurysm) OR direct fistulae (Type A - traumatic or aneurismal) and indirect if dural branches come from the internal carotid or vertebral artery and cannot be embolized selectively
- Subject has a confirmed diagnosis of an intracranial (including intracavernous and intrapetrous regions) sidewall saccular aneurysm or carotid vertebrobasilar fistula
- Parent artery reference diameter is >2.5mm and <4.5mm
- Subject is an adult above age 18
- Subject is able to provide written Informed Consent
- Subject has good general health, is clinically stable, and is considered to be mentally sound
- Subject is able and is willing to meet all expected requirements of the clinical protocol, including attending the scheduled follow-up examinations for the duration of this trial.
Who cannot join
- Subject has subarachnoid hemorrhage (SAH) < three (3) weeks prior to NEC procedure
- Subject has had prior stenting of the target aneurysm.
- Subject is contraindicated for antiplatelet therapy,anticoagulant therapy, or radiographic contrast media.
- Subject has collagen vascular disease.
- Subject has a contraindication to angiography (e.g., serum creatinine level > 2.5 mg/dL)
- Subject has evidence of active infection at the time of treatment
Show all 10Show fewer
- Subject is pregnant or breastfeeding or unwilling to use birth control for duration of study
- Subject has participated in a study involving an investigational drug or device within 30 days prior to proposed entry into subject study
- Subject is unable to comply with study procedures or protocol
- Subject has co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
Kiel, 24105
Olav Jansen, Prof. Dr. med., 0431-587 4808, o.jansen@neurorad.uni-kiel.de
Olav Jansen, Prof. Dr. med.
- Recruiting
Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie
Lübeck, 23538
Christoph Koch, PD Dr. med., 0451-500-4506, koch@neuroradiologie.uni-luebeck.de
Christoph Koch, PD Dr. med.
About this study
Official title: NEC Trial - Nfocus - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae - A Non-Randomized Pilot Study
The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency
Read the detailed description
SAH (subarachnoid hemorrhage) is a devastating medical emergency. As many as 60% of patients who are afflicted die in the first 30 days as a result of the SAH, or remain severely disabled from the bleed. Existing treatment options include: medical management; endovascular therapy and surgical therapy. Endovascular techniques using detachable coils have now been refined to include stents which serve to prevent the coil mass from dislodging. Further improvement is believed to be possible with the NEC which creates a seal to exclude the aneurismal lumen from blood flow without the need for coils. This study involves the endovascular placement of the NEC across the aneurysm neck in order to treat a subset of aneurysms without coils.
- Being tested
- NEC - Neurovascular Embolization Cover
- Medical subject headings
- Intracranial Aneurysm, Carotid-Cavernous Sinus Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEC - Neurovascular Embolization CoverDevice
Implantation of NEC for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistuale arising from a parent vessel of 2.5 to 4.5mm
| Study group | Role | What they receive |
|---|---|---|
| NEC Arm | Experimental | Utilization of NEC (Neurovascular Embolization Cover) for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistulae Receives: Device: NEC - Neurovascular Embolization Cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography
Measured: 6 month follow-up
Proportion of subjects who experience neurologic death or ipsilateral stroke
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nfocus Neuromedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Olav Jansen, Prof. Dr. med., Principal investigator, Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054391
- Sponsor's protocol ID
- NEC001
- Status last verified
- Jan 2010
- First submitted
- 20 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEC Trial - Nfocus - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae - A Non-Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01054391
- Acronym / sponsor ID
- NEC001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nfocus NeuromedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (estimated)
- First posted
- 22 Jan 2010 (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.
The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency
Detailed description
SAH (subarachnoid hemorrhage) is a devastating medical emergency. As many as 60% of patients who are afflicted die in the first 30 days as a result of the SAH, or remain severely disabled from the bleed. Existing treatment options include: medical management; endovascular therapy and surgical therapy. Endovascular techniques using detachable coils have now been refined to include stents which serve to prevent the coil mass from dislodging. Further improvement is believed to be possible with the NEC which creates a seal to exclude the aneurismal lumen from blood flow without the need for coils. This study involves the endovascular placement of the NEC across the aneurysm neck in order to treat a subset of aneurysms without coils.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEC Arm | Experimental | Device: NEC - Neurovascular Embolization CoverUtilization of NEC (Neurovascular Embolization Cover) for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistulae |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of unruptured aneurysm OR ruptured aneurysm in clinically stable patients in whom coils alone are not an efficient treatment in the opinion of the investigator (i.e., large neck or fusiform aneurysm) OR direct fistulae (Type A - traumatic or aneurismal) and indirect if dural branches come from the internal carotid or vertebral artery and cannot be embolized selectively
- Subject has a confirmed diagnosis of an intracranial (including intracavernous and intrapetrous regions) sidewall saccular aneurysm or carotid vertebrobasilar fistula
- Parent artery reference diameter is >2.5mm and <4.5mm
- Subject is an adult above age 18
- Subject is able to provide written Informed Consent
Key exclusion criteria (10 listed)
- Subject has subarachnoid hemorrhage (SAH) < three (3) weeks prior to NEC procedure
- Subject has had prior stenting of the target aneurysm.
- Subject is contraindicated for antiplatelet therapy,anticoagulant therapy, or radiographic contrast media.
- Subject has collagen vascular disease.
- Subject has a contraindication to angiography (e.g., serum creatinine level > 2.5 mg/dL)
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 |
|---|---|---|
| NEC - Neurovascular Embolization CoverImplantation of NEC for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistuale arising from a parent vessel of 2.5 to 4.5mm | Device | NEC Arm |
Primary outcome
Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography
Time frame: 6 month follow-up
Proportion of subjects who experience neurologic death or ipsilateral stroke
Time frame: 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
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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.
Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
Kiel, Germany
Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie
Lübeck, Germany
Olav Jansen, Prof. Dr. med. principal investigator
Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEC - Neurovascular Embolization Cover in people with Intracranial Aneurysms and Cavernous Carotid Fistula, run by Nfocus Neuromedical at 2 sites in Germany.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography (time frame: 6 month follow-up). 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 Jan 2010.