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Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent (CRANIAL-1)

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ClinicalTrials.gov Identifier: NCT02830373
Recruitment Status : Unknown
Verified July 2016 by Qinghai Huang, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Qinghai Huang, 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.

Condition or disease Intervention/treatment
Self Efficacy Medical Device Complication Device: LVIS stents

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Major adverse events (cerebral infarct, death) in 30 days post the procedure [ Time Frame: 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Recurrence rate at 6 months (180±30d) follow-up [ Time Frame: At 6 months (180±30d) follow-up ]
    Recurrence rate: defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830373


Contacts
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Contact: Qinghai Huang, Doctor 13901780638 hqhocin@163.com
Contact: Yongxin Zhang, Doctor 15618711756 yongxinzhang@foxmail.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Pengfei Yang, Doctor    15921196312    15921196312@163.com   
Contact: Yongxin Zhang, Doctor    15618711756    yongxinzhang@foxmail.com   
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Jianmin Liu, Doctor Department of Neurosurgery, Changhai Hospital

Publications of Results:
Other Publications:
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Responsible Party: Qinghai Huang, Deputy Director of Neurosurgery, Clinical Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02830373    
Other Study ID Numbers: CHEC2016-058
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Qinghai Huang, Changhai Hospital:
LVIS stents
Intracranial aneurysm
Unruptured aneurysm
Wide-necked aneurysm
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases