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

• Conditions: Medical Device Complication; Self Efficacy
• Interventions: Device: LVIS stents

• Registration Number: NCT02830373
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-08
• Last Update Submitted: 2016-07-08
• Study First Posted: 2016-07-12
• Last Update Posted: 2016-07-12
• Primary Completion: 2018-06
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LVIS stents group	LVIS stents	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

Primary Outcome Measures

Name	Time	Method
Major adverse events (cerebral infarct, death) in 30 days post the procedure	During 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
Complete occlusion rate at 6 months (180±30d) follow-up	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

Secondary Outcome Measures

Name	Time	Method
Immediate technical success rate (successful device placement)	Within 24 hours postoperatively	Immediate technical successful is defined as good apposition of stents, effective coverage of aneurysmal neck proved by post-procedural imaging examination.
Immediate complete occlusion rate	Within 24 hours postoperatively	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.
Recurrence rate at 6 months (180±30d) follow-up	At 6 months (180±30d) follow-up	Recurrence rate: defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result.
In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up	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.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China