New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population

Unruptured Cerebral Aneurysm Clinical Trial

— NATIONAL-1  

Official title:

New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153865
• Other study ID #: CHEC2017-073
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2017
• Last updated: May 12, 2017
• Start date: June 2, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2017
• Source: Changhai Hospital
• Contact: Pengfei Yang, MD
• Phone: +86 15921196312
• Email: 15921196312[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Treatment Strategy
• Unruptured Cerebral Aneurysm

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the level of psychological states changes	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
Primary	mortality and disability	the rate of death and disable	through study completion, an average of 1 year
Secondary	recurrence rate		1 month, 6 months and 1 year after surgery;
Secondary	progression of disease	enlarge or ruptured of the aneurysm	1 month, 6 months and 1 year after conservative treatment;