Intracranial AneurysmNCT02948504
Chinese Small Intracranial Aneurysm Study (CSIAS)
An observational study of Intracranial Aneurysm and Unruptured Cerebral Aneurysm, run by RenJi Hospital.
Trial summary
Intracranial aneurysms are common in the general population. The overall prevalence of unruptured intracranial aneurysms (UIAs) is estimated of 2.3-3.2% in the population without specific risk factors for SAH. As noninvasive imaging modalities are more commonly used than before, UIAs are increasingly being detected. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Aneurysm, Unruptured Cerebral Aneurysm, Treatment Side Effects
- What is being tested?
- Coiling or Clipping
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Five hundred patients with unruptured aneurysms will registered in this study during the 3 years.
Who may be able to join
- Intracranial unruptured aneurysms confirmed by digital subtraction angiography DSA, CT angiography or MR angiography (MRA);
- The maximum size of unruptured aneurysm ≤5mm;
- Informed consent
Who cannot join
- 1.Patients with severe systemic disorders and expected life span less than one year; 2.Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment of Small Unruptured Intracranial Aneurysms Based on Clinical Characteristics, Morphology and Hemodynamic Features
Intracranial aneurysms are common in the general population. The overall prevalence of unruptured intracranial aneurysms (UIAs) is estimated of 2.3-3.2% in the population without specific risk factors for SAH. As noninvasive imaging modalities are more commonly used than before, UIAs are increasingly being detected. Most patients with small aneurysms (less than 5mm) are incidentally found in clinical practice. Some studies indicate that the majority of patients with UIAs, particularly with small aneurysms (<7mm), have a low risk of rupture, and others have found that small ruptured aneurysms have a high proportion in patients with SAH. Therefore, there is a lot of controversy regarding which small aneurysms can be left untreated, or which aneurysms are needed to be treated with clipping or coiling.
The prevalence varies widely among different detection methods, race/ethnicity or patients with other inherited diseases. Although a wealth of data is available for the natural history of UIAs, the true natural history remains unknown because case selection bias occur in almost all studies. However, data on Chinese UIA is unknown. Using the MR angiography (MRA) to detect aneurysms, the prevalence is 7% of selected adult population in China. Therefore, small UIAs are very common and are increasingly being detected in clinical practice. Conservative treatment, surgical clipping and endovascular coiling are the three treatment options for UIAs. The optimal treatment remains controversial, particularly for small aneurysms (less than 7mm). To date, no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for UIAs. It may be impossible to conduct the randomized controlled study considering aneurysm ruptured as a devastating event. However, surgical clipping or endovascular treatment itself carries a risk of immediate morbidity or mortality. Therefore, a substantial variability widely exists in treatment decision-making for UIAs, and this may lead to a great variability in clinical recommendations.
Our study is a prospective observational study to identify the incidence of rupture of small aneurysms in the first year after the diagnosis of the aneurysm which is left untreated. Meanwhile, we determine the differences of outcomes, procedural complications, and rates of retreatment between surgical clipping and endovascular coiling for small UIAs in China.
Read the detailed description
- Background: There is a lot of controversy regarding which aneurysms can be left untreated, or which aneurysms are needed to be treated with clipping or coiling. To date, no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for small UIAs.
- Study design: A multicenter prospective observation registry study. This study is undertaken to conform to the study protocol. Patients will be recruited between December 2016 and December 2018. Patients are eligible for the study if they meet the inclusion criteria and they are not eligible if any of the following exclusion criteria are met.
- Procedures: All patients were interviewed by a multidisciplinary team that consisted of vascular neurosurgeons, interventional neuroradiologists and anesthetists. If patients meet all of the inclusion criteria: an unruptured aneurysms ≤5mm are enrolled and then followed up at 6 and12 months. Clinical observation, surgical clipping and endovascular coiling are the three treatment options for UIAs. In general, when an UIA is detected, it should be needed to quit smoking, to aggressively manage hypertension, and to control alcohol use. When an aggressive treatment is considered, treatment risks should be balanced against the risk of rupture.
- Being tested
- Coiling or Clipping
- Keywords
- Unruptured Intracranial Aneurysm, Small aneurysms, Risk of rupture, Natural history, Endovascular Coiling, Surgical clipping
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coiling or ClippingProcedure or surgery
All patients are treated under general anesthesia and systemic heparinization. A bolus of 50-75 IU/kg of heparin is given after femoral sheath placement, and intermittent boluses of 1250 IU per hour are given during the procedure. Activated clotting time is maintained at 2-3 times baseline level. Balloon-assisted coiling or stent-assisted coiling are considered in aneurysms with an unfavorable morphology (aneurysm neck≥ 4.0 mm or dome/neck ≤2.0). All anterior circulation aneurysms are clipped through a standard pterional or frontal temporal approach. The posterior circulation aneurysms are treated using far lateral approach depending on the aneurysm location.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Aneurysms are left untreated based on patients and family's wishes. These patients will be included in the observation group. | |
| Coiling or Clipping | Patients are included in the coiling group if they undergo endovascular coiling, such as single coiling, stent-assisted coiling and balloon-assisted coiling. Or Patients are included in the clipping group if they undergo surgical coiling, such as aneurysm neck clipping, aneurysm isolation or trapping. Receives: Procedure: Coiling or Clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rupture of an unruptured aneurysm
These aneurysms are left untreated.
Measured: One year of follow-up
Secondary outcomes (3)
Regrowth of an unruptured aneurysm
Measured: 9 and 12 months of imaging follow-up
Recurrence and retreatment after coiling or clipping
Measured: one year of follow-up
Poor outcome after coiling or clipping
Poor outcome is defined as a mRS 3-6
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jieqing Wan, MD,PHD, Principal investigator, Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948504
- Sponsor's protocol ID
- RJ2016144K1.0
- Status last verified
- Nov 2016
- First submitted
- 26 Oct 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29.
PubMed 20671254Rahman M, Smietana J, Hauck E, Hoh B, Hopkins N, Siddiqui A, Levy EI, Meng H, Mocco J. Size ratio correlates with intracranial aneurysm rupture status: a prospective study. Stroke. 2010 May;41(5):916-20. doi: 10.1161/STROKEAHA.109.574244. Epub 2010 Apr 8.
PubMed 20378866Greving JP, Wermer MJ, Brown RD Jr, Morita A, Juvela S, Yonekura M, Ishibashi T, Torner JC, Nakayama T, Rinkel GJ, Algra A. Development of the PHASES score for prediction of risk of rupture of intracranial aneurysms: a pooled analysis of six prospective cohort studies. Lancet Neurol. 2014 Jan;13(1):59-66. doi: 10.1016/S1474-4422(13)70263-1. Epub 2013 Nov 27.
PubMed 24290159Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.
PubMed 24646873Juvela S, Poussa K, Lehto H, Porras M. Natural history of unruptured intracranial aneurysms: a long-term follow-up study. Stroke. 2013 Sep;44(9):2414-21. doi: 10.1161/STROKEAHA.113.001838. Epub 2013 Jul 18.
PubMed 23868274Guresir E, Vatter H, Schuss P, Platz J, Konczalla J, de Rochement Rdu M, Berkefeld J, Seifert V. Natural history of small unruptured anterior circulation aneurysms: a prospective cohort study. Stroke. 2013 Nov;44(11):3027-31. doi: 10.1161/STROKEAHA.113.001107. Epub 2013 Sep 3.
PubMed 24003049UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
PubMed 22738097Tominari S, Morita A, Ishibashi T, Yamazaki T, Takao H, Murayama Y, Sonobe M, Yonekura M, Saito N, Shiokawa Y, Date I, Tominaga T, Nozaki K, Houkin K, Miyamoto S, Kirino T, Hashi K, Nakayama T; Unruptured Cerebral Aneurysm Study Japan Investigators. Prediction model for 3-year rupture risk of unruptured cerebral aneurysms in Japanese patients. Ann Neurol. 2015 Jun;77(6):1050-9. doi: 10.1002/ana.24400. Epub 2015 Apr 22.
PubMed 25753954Murayama Y, Takao H, Ishibashi T, Saguchi T, Ebara M, Yuki I, Arakawa H, Irie K, Urashima M, Molyneux AJ. Risk Analysis of Unruptured Intracranial Aneurysms: Prospective 10-Year Cohort Study. Stroke. 2016 Feb;47(2):365-71. doi: 10.1161/STROKEAHA.115.010698. Epub 2016 Jan 7.
PubMed 26742803
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Small Unruptured Intracranial Aneurysms Based on Clinical Characteristics, Morphology and Hemodynamic Features
- ClinicalTrials.gov ID
- NCT02948504
- Acronym / sponsor ID
- RJ2016144K1.0
- Keywords
- Unruptured Intracranial Aneurysm, Small aneurysms, Risk of rupture, Natural history, Endovascular Coiling, Surgical clipping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- 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.
Intracranial aneurysms are common in the general population. The overall prevalence of unruptured intracranial aneurysms (UIAs) is estimated of 2.3-3.2% in the population without specific risk factors for SAH. As noninvasive imaging modalities are more commonly used than before, UIAs are increasingly being detected. Most patients with small aneurysms (less than 5mm) are incidentally found in clinical practice. Some studies indicate that the majority of patients with UIAs, particularly with small aneurysms (<7mm), have a low risk of rupture, and others have found that small ruptured aneurysms have a high proportion in patients with SAH. Therefore, there is a lot of controversy regarding which small aneurysms can be left untreated, or which aneurysms are needed to be treated with clipping or coiling.
The prevalence varies widely among different detection methods, race/ethnicity or patients with other inherited diseases. Although a wealth of data is available for the natural history of UIAs, the true natural history remains unknown because case selection bias occur in almost all studies. However, data on Chinese UIA is unknown. Using the MR angiography (MRA) to detect aneurysms, the prevalence is 7% of selected adult population in China. Therefore, small UIAs are very common and are increasingly being detected in clinical practice. Conservative treatment, surgical clipping and endovascular coiling are the three treatment options for UIAs. The optimal treatment remains controversial, particularly for small aneurysms (less than 7mm). To date, no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for UIAs. It may be impossible to conduct the randomized controlled study considering aneurysm ruptured as a devastating event. However, surgical clipping or endovascular treatment itself carries a risk of immediate morbidity or mortality. Therefore, a substantial variability widely exists in treatment decision-making for UIAs, and this may lead to a great variability in clinical recommendations.
Our study is a prospective observational study to identify the incidence of rupture of small aneurysms in the first year after the diagnosis of the aneurysm which is left untreated. Meanwhile, we determine the differences of outcomes, procedural complications, and rates of retreatment between surgical clipping and endovascular coiling for small UIAs in China.
Detailed description
- Background: There is a lot of controversy regarding which aneurysms can be left untreated, or which aneurysms are needed to be treated with clipping or coiling. To date, no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for small UIAs.
- Study design: A multicenter prospective observation registry study. This study is undertaken to conform to the study protocol. Patients will be recruited between December 2016 and December 2018. Patients are eligible for the study if they meet the inclusion criteria and they are not eligible if any of the following exclusion criteria are met.
- Procedures: All patients were interviewed by a multidisciplinary team that consisted of vascular neurosurgeons, interventional neuroradiologists and anesthetists. If patients meet all of the inclusion criteria: an unruptured aneurysms ≤5mm are enrolled and then followed up at 6 and12 months. Clinical observation, surgical clipping and endovascular coiling are the three treatment options for UIAs. In general, when an UIA is detected, it should be needed to quit smoking, to aggressively manage hypertension, and to control alcohol use. When an aggressive treatment is considered, treatment risks should be balanced against the risk of rupture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Aneurysms are left untreated based on patients and family's wishes. These patients will be included in the observation group. |
| Coiling or Clipping | – | Procedure: Coiling or ClippingPatients are included in the coiling group if they undergo endovascular coiling, such as single coiling, stent-assisted coiling and balloon-assisted coiling. Or Patients are included in the clipping group if they undergo surgical coiling, such as aneurysm neck clipping, aneurysm isolation or trapping. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Five hundred patients with unruptured aneurysms will registered in this study during the 3 years.
Key inclusion criteria (3 listed)
- Intracranial unruptured aneurysms confirmed by digital subtraction angiography DSA, CT angiography or MR angiography (MRA);
- The maximum size of unruptured aneurysm ≤5mm;
- Informed consent
Key exclusion criteria (1 listed)
- 1.Patients with severe systemic disorders and expected life span less than one year; 2.Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coiling or ClippingAll patients are treated under general anesthesia and systemic heparinization. A bolus of 50-75 IU/kg of heparin is given after femoral sheath placement, and intermittent boluses of 1250 IU per hour are given during the procedure. Activated clotting time is maintained at 2-3 times baseline level. Balloon-assisted coiling or stent-assisted coiling are considered in aneurysms with an unfavorable morphology (aneurysm neck≥ 4.0 mm or dome/neck ≤2.0). All anterior circulation aneurysms are clipped through a standard pterional or frontal temporal approach. The posterior circulation aneurysms are treated using far lateral approach depending on the aneurysm location. | Procedure or surgery | Coiling or Clipping |
Primary outcome
Rupture of an unruptured aneurysm
Time frame: One year of follow-up
These aneurysms are left untreated.
3 secondary outcomes
Regrowth of an unruptured aneurysm
Time frame: 9 and 12 months of imaging follow-up
Recurrence and retreatment after coiling or clipping
Time frame: one year of follow-up
Poor outcome after coiling or clipping
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Background: PubMed 20671254Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29.
- Background: PubMed 20378866Rahman M, Smietana J, Hauck E, Hoh B, Hopkins N, Siddiqui A, Levy EI, Meng H, Mocco J. Size ratio correlates with intracranial aneurysm rupture status: a prospective study. Stroke. 2010 May;41(5):916-20. doi: 10.1161/STROKEAHA.109.574244. Epub 2010 Apr 8.
- Background: PubMed 24290159Greving JP, Wermer MJ, Brown RD Jr, Morita A, Juvela S, Yonekura M, Ishibashi T, Torner JC, Nakayama T, Rinkel GJ, Algra A. Development of the PHASES score for prediction of risk of rupture of intracranial aneurysms: a pooled analysis of six prospective cohort studies. Lancet Neurol. 2014 Jan;13(1):59-66. doi: 10.1016/S1474-4422(13)70263-1. Epub 2013 Nov 27.
- Background: PubMed 24646873Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.
- Background: PubMed 23868274Juvela S, Poussa K, Lehto H, Porras M. Natural history of unruptured intracranial aneurysms: a long-term follow-up study. Stroke. 2013 Sep;44(9):2414-21. doi: 10.1161/STROKEAHA.113.001838. Epub 2013 Jul 18.
- Background: PubMed 24003049Guresir E, Vatter H, Schuss P, Platz J, Konczalla J, de Rochement Rdu M, Berkefeld J, Seifert V. Natural history of small unruptured anterior circulation aneurysms: a prospective cohort study. Stroke. 2013 Nov;44(11):3027-31. doi: 10.1161/STROKEAHA.113.001107. Epub 2013 Sep 3.
- Background: PubMed 22738097UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
- Background: PubMed 25753954Tominari S, Morita A, Ishibashi T, Yamazaki T, Takao H, Murayama Y, Sonobe M, Yonekura M, Saito N, Shiokawa Y, Date I, Tominaga T, Nozaki K, Houkin K, Miyamoto S, Kirino T, Hashi K, Nakayama T; Unruptured Cerebral Aneurysm Study Japan Investigators. Prediction model for 3-year rupture risk of unruptured cerebral aneurysms in Japanese patients. Ann Neurol. 2015 Jun;77(6):1050-9. doi: 10.1002/ana.24400. Epub 2015 Apr 22.
- Background: PubMed 26742803Murayama Y, Takao H, Ishibashi T, Saguchi T, Ebara M, Yuki I, Arakawa H, Irie K, Urashima M, Molyneux AJ. Risk Analysis of Unruptured Intracranial Aneurysms: Prospective 10-Year Cohort Study. Stroke. 2016 Feb;47(2):365-71. doi: 10.1161/STROKEAHA.115.010698. Epub 2016 Jan 7.
- Individual participant dataSharing planned: No
Related trials for Intracranial Aneurysm
Not yet recruiting
The NUVASCULAR HARBOR Occlusion Device EU Study
Intracranial Arterial Aneurysm
Active, not recruitingPhase 2
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms
Cerebral Aneurysm
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
RecruitingObservational study
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
Intracranial Aneurysm
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.
Jieqing Wan, MD,PHD principal investigator
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Unruptured Cerebral Aneurysm, run by RenJi Hospital.
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 3 inclusion and 1 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Bing Zhao (08613601696475, drzhaobing@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rupture of an unruptured aneurysm (time frame: One year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948504, which also lists 9 linked publications.
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 Nov 2016.