Rationale: Intrasaccular neck occlusion devices have been used for unruptured aneurysm without safety concerns and good occlusion rates. In the setting of a subarachnoid hemorrhage, they could improve the rate of complete occlusion without safety concerns. Aim: To explore the safety and efficacy of intrasaccular neck occlusion devices in patients with acute subarachnoid hemorrhage caused by a ruptured saccular aneurysm by a one arm prospective registry. Study outcome: The primary outcomes is the rate of complete occlusion (Raymond-Roy I) and rebleeding at one year follow-up. The primary safety outcome is rate of rebleeding during the admission.
Study Type
OBSERVATIONAL
Enrollment
120
All patients included will be treated the same: after catheterizing the affected vessel and microcatheterizing the aneurysm with a microcatheter of 0.021'' or 0.027'', the intrasaccular device (Neqstent® or Contour®) will be positioned. Depending of the operator preference, the use of an intrasaccular device could be associated with coiling (mandatory in the case of Neqstent®). Treatment must be performed without previous double antiplatelet treatment (allowing antiplatelet after aneurysm exclusion). Before the treatment all patients should undergo a flat panel CT.
Efficacy achieving the lack of rebleeding
Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding
Time frame: 12 months
Efficacy achieving the complete occlusion
Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at 12 months follow-up evaluated by an image central core lab.
Time frame: 12 months
Analysis of the primary outcomes in different subgroups
Analysis of the primary outcomes in different subgroups: anterior versus vertebrobasilar circulation, narrow versus wide (≥4mm) neck, aneurysm size (\<10mm versus ≥10mm).
Time frame: 12 months
Efficacy achieving the complete occlusion at end of treatment
Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at end of treatment.
Time frame: 1 day
Rate of patients who underwent the study treatment.
Rate of patients who were included in the study and finally underwent the study treatment.
Time frame: 1 days
Rate of retreatment
Rate of retreatment needed during the follow-up.
Time frame: 12 months
Rate of mortality during admission or follow-up.
Rate of mortality during admission or follow-up.
Time frame: 12 months
Functional outcome
Functional outcome at 12 months measured by modified Rankin scale.
Time frame: 12 months
Rate of vascular thrombosis or acute stroke.
Rate of vascular thrombosis or acute stroke during follow-up.
Time frame: 12 months
Rate of early rebleeding.
Rate of early rebleeding during the admission.
Time frame: 30 days.
Rate of complications associated with the procedure.
Rate of complications associated with the procedure.
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.