Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent (CRANIAL-2)

July 8, 2016 updated by: Qinghai Huang, Changhai Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qinghai Huang, Doctor
  • Phone Number: 86-13681973064
  • Email: hqhocin@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients meeting all the following criteria will be enrolled:

    1. Patients of the age 18-75 years old.
    2. Patients diagnosed with ruptured 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LVIS stents group
The patients with ruptured intracranial saccular aneurysm wil be treated with a LVIS stent without coils.
Device: LVIS stent
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete occlusion rate at 6 months (180±30d) follow-up
Time Frame: 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
Major adverse events (cerebral infarct, death) in 30 days post-procedure
Time Frame: During 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
During 30 days post-procedure
Modified Rankin Score at 1 year follow-up
Time Frame: 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.
At 1 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate complete occlusion rate
Time Frame: 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.
Within 24 hours postoperatively
In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up
Time Frame: 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.
At 6 months (180±30d) follow-up
Immediate technical success rate (successful device placement)
Time Frame: 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
Within 24 hours postoperatively
Recurrence rate at 6 months (180±30d) follow-up
Time Frame: At 6 months (180±30d) follow-up
Recurrence rate was defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result.
At 6 months (180±30d) follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Jianmin Liu, Doctor, Department of Neurosurgery, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (ESTIMATE)

July 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2016-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Self Efficacy

Clinical Trials on LVIS stent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe