- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907229
Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms (NCVC-CS1_UAN)
March 11, 2019 updated by: Tetsu Satow, National Cerebral and Cardiovascular Center
Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms: a Multicenter, Uncontrolled, Exploratory Trial
This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms which are difficult to be cured by conventional surgical or endovascular procedures.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kyoto, Japan, 6068507
- Kyoto University Hospital
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Hyogo
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Kobe, Hyogo, Japan, 650-0047
- Kobe City General Hospital
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Osaka
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Suita, Osaka, Japan, 565-8565
- National Cerebral and Cardiovascular Center
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
(Provisional registration)
- Age between 20 and 75 years.
Target lesion is an unruptured aneurysm regardless of prior treatment diagnosed by angiography, CTA, or MRA within 180 days
- Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
- Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
- Target aneurysm with a sac diameter exceeding 7 mm.
- Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than 2.
- Modified Rankin score of 3 or less
- Agreement for participating in the study and informed consent signed by the patient.
(definitive registration)
1. Target lesion must be reconfirmed by angiography or interventional procedure and is compatible with the conditions as follows:
- Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
- Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
- Target aneurysm with a sac diameter exceeding 7 mm.
- Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than 2.
- Parent artery of target aneurysm is accessible by the investigational devices
- The diameter of the parent artery between 3.5 and 5 mm.
Exclusion Criteria:
(Provisional registration)
- Any invasive surgical procedure within 30 days before registration.
- Prior stent implantation at the site of target aneurysm
- Existence of intracranial tumor, arteriovenous malformation for which any intervention is considered necessary, or co-existence of unruptured intracranial aneurysm whose sac diameter over 5mm within the target vessel.
- Coexistence of other unruptured intracranial aneurysms which are planned for intervention
- Target vessel not suitable for delivery and placement of covered stent because of anatomical configuration (i.e. severe bend or tortuosity).
- More than 50% stenosis in the target vessel or its proximity including extracranial region.
- Any intracranial hemorrhage within 42 days before registration.
- Co-morbid conditions that may limit survival to less than 6 months, or difficult to observe the patient for 6 months.
- Renal dysfunction whose serum creatinine more than 2.0
- Contraindications to antiplatelet or anticoagulant treatment because of allergy or hemorrhagic diathesis.
- Platelets less than 100,000/mm3 or known dysfunction of platelets.
- Active bacterial infection.
- Any cardiac, hematological, intracranial, or vessel disease which are considered to have high risk of neurological events (severe cardiac failure, atrial fibrillation, arteritis, known carotid artery stenosis, etc.).
- History of severe allergy to contrast dye.
- Known allergy to cobalt-chromium alloy and polyurethane. clopidogrel, heparin, nitinol, local or general anesthesia
- Subjects who have enrolled, or are planned to participate in other clinical trial or intervention study.
- Pregnant woman
- Unsuitable patients judged by the physician attending this trial.
(definitive registration)
- History of any invasive surgical procedure after the provisional registration.
- Any new neurological signs within 24 hours prior to the procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Treatment group
neuroendovascular therapy(NCVC-CS1)
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Intervention Description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety evaluation: Any stroke or death related to the procedure within 180 days
Time Frame: 180 days after the procedure
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180 days after the procedure
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Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure
Time Frame: 180 days after the procedure
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180 days after the procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Technical success (stent placement in the target lesion covering aneurysmal neck without occlusion of target vessel)
Time Frame: 180 days after the procedure
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180 days after the procedure
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Any death within 180 days after the procedure
Time Frame: 180 days after the procedure
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180 days after the procedure
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Any death by neurological reason within 180 days after the procedure
Time Frame: 180 days after the procedure
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180 days after the procedure
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Any adverse event or adverse device effect
Time Frame: 180 days after the procedure
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180 days after the procedure
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Neurological assessment (scale ; mRS)
Time Frame: 180 days after the procedure
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180 days after the procedure
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Neurological assessment (scale ; Barthel Index)
Time Frame: 180 days after the procedure
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180 days after the procedure
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Neurological assessment (scale ; NIHSS)
Time Frame: 30 days after the procedure
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30 days after the procedure
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Neurological assessment (scale ; GCS)
Time Frame: 30 days after the procedure
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30 days after the procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tetsu Satow, National Cerebral and Cardiovascular Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2016
Primary Completion (ACTUAL)
January 25, 2019
Study Completion (ACTUAL)
March 4, 2019
Study Registration Dates
First Submitted
September 1, 2016
First Submitted That Met QC Criteria
September 15, 2016
First Posted (ESTIMATE)
September 20, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCVC-CS1_UAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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