Chinese Small Intracranial Aneurysm Study (CSIAS)

Intracranial Aneurysm Clinical Trial

Official title:

Treatment of Small Unruptured Intracranial Aneurysms Based on Clinical Characteristics, Morphology and Hemodynamic Features

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02948504
• Other study ID #: RJ2016144K1.0
• Status: Not yet recruiting
• Phase: N/A
• First received: October 26, 2016
• Last updated: November 14, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: RenJi Hospital
• Contact: Bing Zhao
• Phone: 08613601696475
• Email: drzhaobing[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Observational

Clinical 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. 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.

Description:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Intracranial unruptured aneurysms confirmed by digital subtraction angiography DSA, CT angiography or MR angiography (MRA);

2. The maximum size of unruptured aneurysm =5mm;

3. Informed consent

Exclusion Criteria:

1.Patients with severe systemic disorders and expected life span less than one year; 2.Pregnant or lactating women.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Treatment Side Effects
• Unruptured Cerebral Aneurysm

Intervention

Procedure:
• Coiling or Clipping
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

References & Publications (9)

Brown 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. Review. — View Citation

Greving 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. Review. — View Citation

Güresir 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. — View Citation

Juvela 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. — View Citation

Murayama 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. — View Citation

Rahman 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. — View Citation

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. — View Citation

Tominari 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. — View Citation

UCAS 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural complications		30 days after coiling or clipping	No
Primary	Rupture of an unruptured aneurysm	These aneurysms are left untreated.	One year of follow-up	No
Secondary	Regrowth of an unruptured aneurysm		9 and 12 months of imaging follow-up	No
Secondary	Recurrence and retreatment after coiling or clipping		one year of follow-up	No
Secondary	Poor outcome after coiling or clipping	Poor outcome is defined as a mRS 3-6	6 and 12 months	No