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Self EfficacyCRANIAL-2NCT02830386

Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent

An observational study of Self Efficacy and Medical Device Complication, run by Changhai Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Self Efficacy, Medical Device Complication
What is being tested?
LVIS stent
Type of treatment
Medical device
How many people
200 participants
Where
1 siteChina
Study dates
Jun 2016to Nov 2018
Phase
Observational
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The targeted population was the patients with ruptured intracranial saccular aneurysms which located in the internal carotid artery or vertebra-basilar artery.

Who may be able to join

  • Patients meeting all the following criteria will be enrolled:
  • Patients of the age 18-75 years old.
  • Patients diagnosed with ruptured intracranial saccular aneurysms via CTA, MRA or DSA.
  • Patients treated with LVIS stents combined with coils.
  • Patients willing to follow the clinical trial instructions and receive follow-up assessment.
  • Patients accepting to participate to the study and sign the consent forms.

Who cannot join

  • Patients meeting any following criterion will be excluded
  • Patients without proper artery approach.
  • Patients with AVM.
  • Patients with a fusiform or dissecting aneurysm.
  • Patients with a recurrent aneurysm.
  • Patients treated with a LVIS stent without coils.
Show all 12Show fewer
  • Patients in poor clinical status, with mRS ≥4.
  • Patients with life expectancy less than 12 months.
  • Patients participated in other clinical trial, while has not reach the primary endpoint.
  • Patients can not accept anti-platelet regimen.
  • Patients allergic to contrast agent or intolerable.
  • Patients whom the researchers consider should not participate in or continue this clinical trial.

Trial locations and contacts

1 site in 1 country.

Qinghai Huang, Doctor contact

86-13681973064

hqhocin@163.com

Yongxin Zhang, Doctor contact

15618711756

yongxinzhang@foxmail.com

China1 site, 1 recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Pengfei Yang, Doctor, 15921196312, 15921196312@163.com

    Yongxin Zhang, Doctor, 15618711756, yongxinzhang@foxmail.com

    Recruiting

Other trials in China

About this study

Official title: Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.

Read the detailed description

This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of ruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (±7 days) after procedure, DSA or MRA follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up, and modified Rankin Score (mRS) at 1 year follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.

Being tested
LVIS stent

What participants receive

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

  • LVIS stentDevice

    Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.

Study groups in NCT02830386
Study groupRoleWhat they receive
LVIS stents groupThe patients with ruptured intracranial saccular aneurysm wil be treated with a LVIS stent without coils.
Receives: Device: LVIS stent

What is being measured

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

  1. Major adverse events (cerebral infarct, death) in 30 days post-procedure

    Major adverse events (cerebral infarct, death) in 30 days post the procedure is defined as post-procedural cerebral infarct or death caused by any reasons

    Measured: During 30 days post-procedure

  2. Complete occlusion rate at 6 months (180±30d) follow-up

    Complete occlusion at 6 months follow-up is defined as 100% occlusion of aneurysmal sac proved by DSA at 6 months follow-up

    Measured: At 6 months (180±30d) follow-up

  3. Modified Rankin Score at 1 year follow-up

    The scale runs from 0-6, running from perfect health without symptoms to death.

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

    Measured: At 1 year follow-up

Secondary outcomes (4)

  1. Immediate technical success rate (successful device placement)

    Immediate technical successful is defined as good apposition of stents, effective coverage of aneurysmal neck proved by post-procedural imaging examination

    Measured: Within 24 hours postoperatively

  2. Immediate complete occlusion rate

    Immediate Raymond scale is defined as immediate angiographic result according to the simplified Raymond scale, classⅠ: complete occlusion; class Ⅱ: neck remnant; class Ⅲ: incomplete occlusion.

    Measured: Within 24 hours postoperatively

  3. Recurrence rate at 6 months (180±30d) follow-up

    Recurrence rate was defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result.

    Measured: At 6 months (180±30d) follow-up

  4. In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up

    In-stent stenosis at 6 months follow-up is defined as stenosis more than 50% proved by DSA at 6 months follow-up. In-stent occlusion or thrombosis at 6 months follow-up is defined as complete occlusion of the stent proved by DSA at 6 months follow-up.

    Measured: At 6 months (180±30d) follow-up

Timeline

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

  1. First posted12 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02830386
Sponsor's protocol ID
CHEC2016-059
Acronym
CRANIAL-2
Status last verified
Jul 2016
First submitted
6 Jul 2016
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Hong Y, Wang YJ, Deng Z, Wu Q, Zhang JM. Stent-assisted coiling versus coiling in treatment of intracranial aneurysm: a systematic review and meta-analysis. PLoS One. 2014 Jan 15;9(1):e82311. doi: 10.1371/journal.pone.0082311. eCollection 2014.

    PubMed 24454690

  • Geyik S, Yavuz K, Yurttutan N, Saatci I, Cekirge HS. Stent-assisted coiling in endovascular treatment of 500 consecutive cerebral aneurysms with long-term follow-up. AJNR Am J Neuroradiol. 2013 Nov-Dec;34(11):2157-62. doi: 10.3174/ajnr.A3574. Epub 2013 Jul 25.

    PubMed 23886748

  • Poncyljusz W, Bilinski P, Safranow K, Baron J, Zbroszczyk M, Jaworski M, Bereza S, Burke TH. The LVIS/LVIS Jr. stents in the treatment of wide-neck intracranial aneurysms: multicentre registry. J Neurointerv Surg. 2015 Jul;7(7):524-9. doi: 10.1136/neurintsurg-2014-011229. Epub 2014 May 14.

    PubMed 24827067

  • Fiorella D, Arthur A, Boulos A, Diaz O, Jabbour P, Pride L, Turk AS, Woo HH, Derdeyn C, Millar J, Clifton A. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. J Neurointerv Surg. 2016 Sep;8(9):894-7. doi: 10.1136/neurintsurg-2015-011937. Epub 2015 Sep 21.

    PubMed 26391016

  • Yang P, Zhao K, Zhou Y, Zhao R, Zhang L, Zhao W, Hong B, Xu Y, Huang Q, Krings T, Liu J. Stent-assisted Coil Placement for the Treatment of 211 Acutely Ruptured Wide-necked Intracranial Aneurysms: A Single-Center 11-Year Experience. Radiology. 2015 Aug;276(2):545-52. doi: 10.1148/radiol.2015140974. Epub 2015 Mar 30.

    PubMed 25822469

  • Feng Z, Fang Y, Xu Y, Hong B, Zhao W, Liu J, Huang Q. The safety and efficacy of low profile visualized intraluminal support (LVIS) stents in assisting coil embolization of intracranial saccular aneurysms: a single center experience. J Neurointerv Surg. 2016 Nov;8(11):1192-1196. doi: 10.1136/neurintsurg-2015-012090. Epub 2016 Jan 8.

    PubMed 26747876

  • Cho YD, Sohn CH, Kang HS, Kim JE, Cho WS, Hwang G, Kwon OK, Ko MS, Park NM, Han MH. Coil embolization of intracranial saccular aneurysms using the Low-profile Visualized Intraluminal Support (LVIS) device. Neuroradiology. 2014 Jul;56(7):543-51. doi: 10.1007/s00234-014-1363-x. Epub 2014 Apr 17.

    PubMed 24740581

Questions about this trial

What is this clinical trial studying?

An observational study of Self Efficacy and Medical Device Complication, run by Changhai Hospital at 1 site in China.

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 6 inclusion and 12 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 12 Jul 2016. 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 China. 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?

Contact Qinghai Huang, Doctor (86-13681973064, hqhocin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse events (cerebral infarct, death) in 30 days post-procedure (time frame: During 30 days post-procedure). 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?

On the ClinicalTrials.gov record for NCT02830386, which also lists 7 linked publications.

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 12 Jul 2016.

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