Clinical trial NCT02830373: Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
Official title: Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Self Efficacy
Medical Device Complication
Keywords: LVIS stents
Intracranial aneurysm
Unruptured aneurysm
Wide-necked aneurysm
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

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 unruptured 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients meeting all the following criteria will be enrolled:

  1. Patients of the age 18-75 years old.
  2. Patients diagnosed with unruptured intracranial saccular aneurysms via CTA, MRA or DSA.
  3. Patients treated with LVIS stents combined with coils.
  4. Patients willing to follow the clinical trial instructions and receive follow-up assessment.
  5. Patients accepting to participate to the study and sign the consent forms.

Exclusion Criteria:

* Patients meeting any following criterion will be excluded:

  1. Patients without proper artery approach.
  2. Patients with AVM.
  3. Patients with a fusiform or dissecting aneurysm.
  4. Patients with a recurrent aneurysm.
  5. Patients treated with a LVIS stent without coils.
  6. Patients in poor clinical status, with mRS ≥4.
  7. Patients with life expectancy less than 12 months.
  8. Patients participated in other clinical trial, while has not reach the primary endpoint.
  9. Patients can not accept anti-platelet regimen.
  10. Patients allergic to contrast agent or intolerable.
  11. Patients whom the researchers consider should not participate in or continue this clinical trial.

Primary outcomes:
measure: Major adverse events (cerebral infarct, death) in 30 days post the procedure
timeFrame: During 30 days post the procedure
measure: Complete occlusion rate at 6 months (180±30d) follow-up
timeFrame: At 6 months (180±30d) follow-up
Secondary outcomes:
measure: Immediate technical success rate (successful device placement)
timeFrame: Within 24 hours postoperatively
measure: Immediate complete occlusion rate
timeFrame: Within 24 hours postoperatively
measure: Recurrence rate at 6 months (180±30d) follow-up
timeFrame: At 6 months (180±30d) follow-up
measure: In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up
timeFrame: At 6 months (180±30d) follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Neurosurgery, Changhai Hospital
name: Jianmin Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.