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Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics of Treatment of IA Using Stents

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ClinicalTrials.gov Identifier: NCT03387995
Recruitment Status : Active, not recruiting
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Intracranial aneurysms (IA) regarded the third cause of cerebral vascular disease is the majoy cause of subarachnoid hemorrhage (SAH). The mortality and morbidity account for 22% to 25% in cerebrovascular disease. More than half of the ruptured IA survivors has serious nerve dysfunction such as hemiplegia, aphasia,which seriously harms to human health. Endovascular embolization is one of the main treatment ways of IA.However,there are no studies on the multicenter cases of stent selection strategy at home and abroad.Therefore, the investigators conduct a prospective study by comparing the clinical efficacy, follow-up results, and hemodynamics between preoperative and postoperative patients with different types of stent assisted embolization treatment of IA.The investigators also study the relationship between cyclin dependent kinase inhibitor 2B antisense RNA 1 gene(CDKN2BAS1 gene)of IA patients and the results, for making indication of stents, improving the cure rate, reducing the recurrence rate of IA patients, providing theory gist for interventional therapy of complex IA and simplying slection of stent.

Condition or disease Intervention/treatment
Treatment Outcome by Stent-assisted Embolization Device: LVIS stent Device: Solitire stent Device: Enterprise stent Device: Neuroform stent Device: Pipeline stent

Detailed Description:

Studies showed 3.6% - 6% for the incidence and 1% - 2% for the ruptctued rate of IA.The mortality and morbidity account for 22% to 25% in cerebrovascular disease ,which is a growing trend. IA is one of the major diseases which relate with people's living standards. Endovascular embolization is one of the main treatments of IA with less invasive, Better cure rates and higher safety. It has been developed rapidly and improve quality of patients' lives after treatmen.With the rapid development of neural intervention and the proliferation of specialized stents in IA, stent-assisted embolization technique is becoming more and more common .Especially, stents play an important role in intracranial aneurysmal aneurysm.

There are many kinds intracranial stents for clinical surgery, but how to choose the appropriate stent type is one of the key issues that clinicians need to settle. And, there is no relevant multicenter cases study about selection strategy of intracranial stent at home and abroad.


Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: the Treatment of Intracranial Aneurysm Using Different Types of Stents Assisted Embolization :Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Anterior communicating artery aneurysm
Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent.
Device: LVIS stent
The group has 80 patients.
Device: Solitire stent
The group has 80 patients.
Device: Enterprise stent
The group has 80 patients.
Device: Neuroform stent
The group has 80 patients.
Device: Pipeline stent
The group has 80 patients.
Middle cerebral artery aneurysm
Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent.
Device: LVIS stent
The group has 80 patients.
Device: Solitire stent
The group has 80 patients.
Device: Enterprise stent
The group has 80 patients.
Device: Neuroform stent
The group has 80 patients.
Device: Pipeline stent
The group has 80 patients.
Posterior communicating artery aneurysm
Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent.
Device: LVIS stent
The group has 80 patients.
Device: Solitire stent
The group has 80 patients.
Device: Enterprise stent
The group has 80 patients.
Device: Neuroform stent
The group has 80 patients.
Device: Pipeline stent
The group has 80 patients.
Internal carotid artery aneurysm
Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent.
Device: LVIS stent
The group has 80 patients.
Device: Solitire stent
The group has 80 patients.
Device: Enterprise stent
The group has 80 patients.
Device: Neuroform stent
The group has 80 patients.
Device: Pipeline stent
The group has 80 patients.
Vertebrobasilar system aneurysms
Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent.
Device: LVIS stent
The group has 80 patients.
Device: Solitire stent
The group has 80 patients.
Device: Enterprise stent
The group has 80 patients.
Device: Neuroform stent
The group has 80 patients.
Device: Pipeline stent
The group has 80 patients.


Outcome Measures

Primary Outcome Measures :
  1. The security evaluation of interventional therapy [ Time Frame: 6 months later after operation ]
    Modified Rankin score to measure the security of of interventional therapy


Other Outcome Measures:
  1. The effectiveness evaluation of interventional treatment [ Time Frame: 6 months later after operation ]
    Raymond scale to measure the effectiveness of interventional treatment

  2. The hemodynamics of parent artery after interventional treatment [ Time Frame: 1year later after operation ]
    The curvature of parent artery will be measured by DSA or 3D-DSA

  3. Evaluate the relationship between intracranial aneurysm and cyclin dependent kinase inhibitor 2B antisense RNA1(CDKN2BAS1) [ Time Frame: 6 months later after operation ]
    The investigators will take the participant's blood and the relationship between intracranial aneurysm and CDKN2BAS1 will be evaluated by ligase detection reaction-polymerase chain reaction(LDP-PCR)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography(DSA).
Criteria

Inclusion Criteria:

  • Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography(DSA)
  • Subject has accepted stent - assisted embolization treatment of intracranial aneurysm

Exclusion Criteria:

  • Subject has secondary intracranial aneurysms(e.g.traumatic aneurysm, infected aneurysm)
  • Subject has received surgical clipping or endovascular treatment
  • Subject has no intracranial aneurysms by DSA
  • Subject has no aneurysm measurement
  • Aneurysm of patients are not clear by imaging
  • Subject cannot use stent because of the small parent artery
  • Subject do not need to use stent because of narrow-neck aneurysm
  • History of aneurysm
Contacts and Locations

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): NCT03387995


Locations
China, Guangdong
ZhuJiang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital
Nanfang Hospital of Southern Medical University
Guangdong General Hospital
Investigators
Principal Investigator: Chuanzhi Duan, Ph.D. Department of Neurosurgery, Zhujiang Hospital,Southern Medical University
More Information

Publications:

Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03387995     History of Changes
Other Study ID Numbers: LC2016ZD024
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: invertigators can share the original data 5 years after the study

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhujiang Hospital:
treatment outcome