WP6 – SAfety oF Endovascular devices for Treatment of recently ruptured aneurYsms(SAFETY)
Mervyn Vergouwen (UMCU) & Jeroen Boogaarts (RUMC)
One of the most important determinants of poor outcome after aSAH is rebleeding of the aneurysm. The risk of rebleeding can be diminished or, ideally, obviated by endovascular or neurosurgical treatment of the aneurysm. For decades, neurosurgical clipping was the standard treatment for a ruptured aneurysm. After publication of the ISAT trial, endovascular coiling became the preferred method, if both clipping and coiling were eligible. Additionally, over the last decade advanced endovascular treatment options were introduced, such as balloon- or stent-assisted coiling, flow diverting stents, and intrasaccular devices. Despite these advances and benefits of new endovascular techniques and materials, procedures might also have higher complication rates compared to standard coiling.
Several (mostly single-centre) SAH registries in the world have increased our knowledge on SAH-disease-specific complications (such as rebleeding, delayed cerebral ischemia, hydrocephalus) and long-term outcomes. Registries usually focused on the prevention and treatment of these disease-specific complications and functional or cognitive outcomes, however, they did not capture data on this novel endovascular armamentarium. In this study we hypothesize that the risk of advanced endovascular techniques is higher than of standard coiling and related to the complexity of the procedure.
Overall objective: To determine the safety of various endovascular devices for treatment of a recently ruptured intracranial aneurysm, and to compare it with the safety of neurosurgical clipping.
- To determine the risk of complications related to endovascular treatment of a recently ruptured intracranial aneurysm.
- To compare the risk of complications related to aneurysm coiling with the risk of complications related to different types of ‘advanced’ endovascular treatments of a recently ruptured intracranial aneurysm.
- To design a prediction model for the risk of complications related to endovascular treatment of a recently ruptured intracranial aneurysm
- To investigate the potential benefit of treatment of a recently ruptured wide-neck aneurysm with an ‘advanced’ endovascular device compared to neurosurgical clipping
- To investigate the potential benefit of treatment of a recently ruptured small-neck aneurysm with an intrasaccular device compared to ‘simple/bare coiling’