New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population (NATIONAL-1)

May 12, 2017 updated by: Qinghai Huang, Changhai Hospital
This is a prospective, multicenter, observational study, aiming at comparing the Safety and effectiveness among the different surgical treatment of unruptured intracranial aneurysms in China, so as to improve the diagnosis and treatment of unruptured intracranial aneurysms.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with unruptured intracranial saccular aneurysm at all age.

Description

Inclusion Criteria:

  • patients diagnosed with unruptured intracranial saccular aneurysm on CTA, MRA or DSA.
  • patients willing to participate in this clinical trial and attach to regular follow up.

Exclusion Criteria:

  • intracranial aneurysm correlating to AVM.
  • intracranial non-saccular aneurysm.
  • the rupture or unrpture of the aneurysm confirmed on CTA、MRA or DSA.
  • patients unwilling to participate in this clinical trial and attach to regular follow up.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality and disability
Time Frame: through study completion, an average of 1 year
the rate of death and disable
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: 1 month, 6 months and 1 year after surgery;
1 month, 6 months and 1 year after surgery;
progression of disease
Time Frame: 1 month, 6 months and 1 year after conservative treatment；
enlarge or ruptured of the aneurysm
1 month, 6 months and 1 year after conservative treatment；

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the level of psychological states changes
Time Frame: 1 month, 6 months and 1 year after been aware of the disease
The Sheet for Affective Disorders was used to record the level of psychological states changes in every participant when they were aware of the disease.
1 month, 6 months and 1 year after been aware of the disease

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Qinghai Huang, MD, Changhai Hospital

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 (Anticipated)

June 2, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2017-073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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