Unruptured Cerebral AneurysmNATIONAL-1NCT03153865
New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population
An observational study of Unruptured Cerebral Aneurysm and Treatment Strategy, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unruptured Cerebral Aneurysm, Treatment Strategy
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed with unruptured intracranial saccular aneurysm at all age.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Pengfei Yang, MD, +86 15921196312, 15921196312@me.com
About this study
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.
- Conditions
- Unruptured Cerebral Aneurysm, Treatment Strategy
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality and disability
the rate of death and disable
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
recurrence rate
Measured: 1 month, 6 months and 1 year after surgery;
progression of disease
enlarge or ruptured of the aneurysm
Measured: 1 month, 6 months and 1 year after conservative treatment；
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start2 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinghai Huang, Changhai Hospital
- Investigators
- Qinghai Huang, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153865
- Sponsor's protocol ID
- CHEC2017-073
- Acronym
- NATIONAL-1
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population
- ClinicalTrials.gov ID
- NCT03153865
- Acronym / sponsor ID
- NATIONAL-1 / CHEC2017-073
- Conditions
- Unruptured Cerebral Aneurysm, Treatment Strategy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 2 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with unruptured intracranial saccular aneurysm at all age.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality and disability
Time frame: through study completion, an average of 1 year
the rate of death and disable
2 secondary outcomes
recurrence rate
Time frame: 1 month, 6 months and 1 year after surgery;
progression of disease
Time frame: 1 month, 6 months and 1 year after conservative treatment；
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinghai Huang, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Cerebral Aneurysm and Treatment Strategy, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Yang, MD (+86 15921196312, 15921196312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality and disability (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.