Intracranial AneurysmNCT02609867
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
A study testing Flowise Cerebral Flow Diverter in people with Intracranial Aneurysm, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Flowise Cerebral Flow Diverter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2015to 22 Jan 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional neurological state ≤2 mRS
- Unruptured wide-neck aneurysm in the internal carotid artery has a size >8mm, a neck ≥4mm, or dome/neck ratio <2
- Parent artery with diameter ≥3.25mm and ≤4.5mm
- Patient willing to provide written informed consent and comply with follow-up requirements
Who cannot join
- Intracranial hemorrhage within 30 days
- Untreated ruptured intracranial aneurysm
- ≥1 intracranial aneurysm except the target one requires treatment within 6 months
- Immunosuppressive disease
- Active infectious disease (e.g. endocarditis, meningitis)
- Platelet count < 100 x 103 cells/mm3
- Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Healthcare System, Severance Hospital
Seoul, Yeonsei-ro Seodaemun-gu, 03722
About this study
Official title: A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.
Read the detailed description
Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.
- Conditions
- Intracranial Aneurysm
- Being tested
- Flowise Cerebral Flow Diverter
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flowise Cerebral Flow DiverterDevice
Flowise Cerebral Flow Diverter Placement
| Study group | Role | What they receive |
|---|---|---|
| Flowise Cerebral Flow Diverter | Experimental | Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea) Receives: Device: Flowise Cerebral Flow Diverter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Procedural success is defined as the full expansion of the Flowise identified on angiography and the full coverage of the targeted aneurysm neck in the absence of periprocedural stroke or death.
Measured: 5days
≥50% intracranial aneurysm size reduction success at 6 month
Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).
Measured: 6months
Aneurysm occlusion success at 6month
Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
Measured: 6months
Secondary outcomes (5)
≥50% Parent artery stenosis or occlusion
Measured: 6months
Newly developed neurological disorder
Newly developed neurological disorder is defined as neurological problem lasts for at least 1 month post procedure and ≥3 modified Rankin Scale (mRS).
Measured: 6months
Ipsilateral stroke
Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).
Measured: 6months
30-day death
30-day death was defined as death within 30 days post procedure.
Measured: 6months
Other adverse events
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start23 Oct 2015
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Buyng Moon Kim, PhD. MD, Principal investigator, Yonsei University Healthcare System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609867
- Sponsor's protocol ID
- FDV-001
- Status last verified
- Jul 2019
- First submitted
- 17 Nov 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery
- ClinicalTrials.gov ID
- NCT02609867
- Acronym / sponsor ID
- FDV-001
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 20 Nov 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.
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.
Detailed description
Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flowise Cerebral Flow Diverter | Experimental | Device: Flowise Cerebral Flow DiverterFlowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Functional neurological state ≤2 mRS
- Unruptured wide-neck aneurysm in the internal carotid artery has a size >8mm, a neck ≥4mm, or dome/neck ratio <2
- Parent artery with diameter ≥3.25mm and ≤4.5mm
- Patient willing to provide written informed consent and comply with follow-up requirements
Key exclusion criteria (7 listed)
- Intracranial hemorrhage within 30 days
- Untreated ruptured intracranial aneurysm
- ≥1 intracranial aneurysm except the target one requires treatment within 6 months
- Immunosuppressive disease
- Active infectious disease (e.g. endocarditis, meningitis)
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 |
|---|---|---|
| Flowise Cerebral Flow DiverterFlowise Cerebral Flow Diverter Placement | Device | Flowise Cerebral Flow Diverter |
Primary outcome
Procedural success
Time frame: 5days
Procedural success is defined as the full expansion of the Flowise identified on angiography and the full coverage of the targeted aneurysm neck in the absence of periprocedural stroke or death.
≥50% intracranial aneurysm size reduction success at 6 month
Time frame: 6months
Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).
Aneurysm occlusion success at 6month
Time frame: 6months
Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
5 secondary outcomes
≥50% Parent artery stenosis or occlusion
Time frame: 6months
Newly developed neurological disorder
Time frame: 6months
Ipsilateral stroke
Time frame: 6months
30-day death
Time frame: 6months
Other adverse events
Time frame: 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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.
Buyng Moon Kim, PhD. MD principal investigator
Yonsei University Healthcare System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flowise Cerebral Flow Diverter in people with Intracranial Aneurysm, run by Yonsei University at 1 site in South Korea.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 5 Jul 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Procedural success (time frame: 5days). The study lists 3 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 5 Jul 2019.