An observational study in Intracranial Aneurysm, Unruptured Cerebral Aneurysm and Treatment Side Effects, sponsored by RenJi Hospital. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by RenJi Hospital · Observational
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Five hundred patients with unruptured aneurysms will registered in this study during the 3 years.
Exclusion Criteria:
1.Patients with severe systemic disorders and expected life span less than one year; 2.Pregnant or lactating women.
Aneurysms are left untreated based on patients and family's wishes. These patients will be included in the observation group.
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.
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.
Rupture of an unruptured aneurysm
These aneurysms are left untreated.
Time frame: One year of follow-up
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
Poor outcome is defined as a mRS 3-6
Time frame: 6 and 12 months
Procedural complications
Time frame: 30 days after coiling or clipping
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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RenJi Hospital