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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

— NATIONAL-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153748
• Other study ID #: CHEC2017-074
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2017
• Last updated: May 12, 2017
• Start date: July 1, 2016
• 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 [Patient Registry]

Clinical Trial Summary

This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• 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 presented with subarachnoid hemorrhage on CT or lumbar puncture.

• the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed 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.

• dissection, false, traumatic and infectious aneurysms.

• the rupture of the aneurysm can not be 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
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

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
Primary	mRS score	the mRS score after treatment	1 year after treatment
Primary	cure rate	the proportion of the cured-patient according Raymond Class	6 months after treatment
Secondary	recurrence rate	the proportion of the recurrence of the patient	through study completion, an average of 1 year
Secondary	complication rate	the proportion of complication happened after treatment including ischemic, hemorrhage, retreat, and so on	through study completion, an average of 1 year