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Intracranial AneurysmNCVC-CS1_UANNCT02907229

Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms

A study testing NCVC-CS1 in people with Intracranial Aneurysm, run by National Cerebral and Cardiovascular Center, Japan at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
NCVC-CS1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesJapan
Study dates
May 2016to 4 Mar 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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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.
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  • 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.

Who cannot join

  • (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).
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Kobe City General Hospital

    Kobe, Hyōgo, 650-0047

  • Kyoto University Hospital

    Kyoto, 6068507

  • National Cerebral and Cardiovascular Center

    Suita, Osaka, 565-8565

Other trials in Japan

About this study

Official title: 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.

Being tested
NCVC-CS1
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NCVC-CS1Device

    Intervention Description

Study groups in NCT02907229
Study groupRoleWhat they receive
Treatment groupExperimentalneuroendovascular therapy(NCVC-CS1)
Receives: Device: NCVC-CS1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety evaluation: Any stroke or death related to the procedure within 180 days

    Measured: 180 days after the procedure

  2. 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

    Measured: 180 days after the procedure

Secondary outcomes (8)

  1. Technical success (stent placement in the target lesion covering aneurysmal neck without occlusion of target vessel)

    Measured: 180 days after the procedure

  2. Any death within 180 days after the procedure

    Measured: 180 days after the procedure

  3. Any death by neurological reason within 180 days after the procedure

    Measured: 180 days after the procedure

  4. Any adverse event or adverse device effect

    Measured: 180 days after the procedure

  5. Neurological assessment (scale ; mRS)

    Measured: 180 days after the procedure

  6. Neurological assessment (scale ; Barthel Index)

    Measured: 180 days after the procedure

  7. Neurological assessment (scale ; NIHSS)

    Measured: 30 days after the procedure

  8. Neurological assessment (scale ; GCS)

    Measured: 30 days after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion25 Jan 2019
  4. Study completion4 Mar 2019

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907229
Sponsor's protocol ID
NCVC-CS1_UAN
Acronym
NCVC-CS1_UAN
Status last verified
Mar 2019
First submitted
1 Sep 2016
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Yamamoto H, Hamasaki T, Onda K, Nakayama Y, Ishii A, Oishi H, Sakai N, Satow T. Evaluating the safety and technical effectiveness of a newly developed intravascular 'flow isolator' stent for the treatment of intracranial aneurysms: study protocol for a first-in-human single-arm multiple-site clinical trial in Japan. BMJ Open. 2019 May 9;9(5):e020966. doi: 10.1136/bmjopen-2017-020966.

    PubMed 31072845

Questions about this trial

What is this clinical trial studying?

A study testing NCVC-CS1 in people with Intracranial Aneurysm, run by National Cerebral and Cardiovascular Center, Japan at 4 sites in Japan.

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 17 inclusion and 22 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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?

Safety evaluation: Any stroke or death related to the procedure within 180 days (time frame: 180 days after the procedure). 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?

On the ClinicalTrials.gov record for NCT02907229, which also lists 1 linked publication.

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 13 Mar 2019.

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