NCT02830373

Brief Summary

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular aneurysms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 6, 2016

Last Update Submit

July 8, 2016

Conditions

Self EfficacyMedical Device Complication

Keywords

LVIS stentsIntracranial aneurysmUnruptured aneurysmWide-necked aneurysm

Outcome Measures

Primary Outcomes (2)

  • Major adverse events (cerebral infarct, death) in 30 days post the 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

    During 30 days post the procedure

  • 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

    At 6 months (180±30d) follow-up

Secondary Outcomes (4)

  • Immediate technical success rate (successful device placement)

    Within 24 hours postoperatively

  • Immediate complete occlusion rate

    Within 24 hours postoperatively

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

    At 6 months (180±30d) follow-up

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

    At 6 months (180±30d) follow-up

Study Arms (1)

LVIS stents group

patients with unruptured intracranial saccular aneurysms which located in the internal carotid artery or vertebra-basilar artery will be treated with a LVIS stent with coils

Device: LVIS stents

Interventions

LVIS stentsDEVICE

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

LVIS stents group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients meeting all the following criteria will be enrolled:
  • Patients of the age 18-75 years old.
  • Patients diagnosed with unruptured 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 24454690BACKGROUND

  • 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.

    PMID: 23886748BACKGROUND

  • 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.

    PMID: 24827067BACKGROUND

  • 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.

    PMID: 26747876RESULT

  • 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.

    PMID: 26391016RESULT

  • 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.

    PMID: 24740581RESULT

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Jianmin Liu, Doctor

    Department of Neurosurgery, Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghai Huang, Doctor

CONTACT

13901780638hqhocin@163.com

Yongxin Zhang, Doctor

CONTACT

15618711756yongxinzhang@foxmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Neurosurgery, Clinical Professor

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 12, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

October 1, 2018

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CN(1)