Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE

Study Overview
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Brief Summary
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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.

Official Title
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Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE

Conditions
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Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
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* Device: Neqstent or Contour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute subarachnoid hemorrhage due to an intracranial ruptured aneurysm. Diagnosis must be done with acute CT or MRI. Intracranial saccular aneurysm with neck diameter 2-11mm and neck-dome height ≥2 mm. Clinical severity measured by World Federation Neurological Surgeons scale score ≤ III. Age ≥18 years. Previous modified Rankin scale ≤2. Informed consent obtained from the patient or acceptable patient surrogate. Exclusion Criteria: Hemodynamically unstable patients with requirement of advanced vital support. Patients with limited life expectancy (<6 months) due to terminal disease. Previous antiplatelet or anticoagulation treatment. Participation in any other clinical trial with a drug or device which could influence the outcome. Patients with neurological or psychiatric disease that could undermine future evaluations. Lack of availability for 12 months tracing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neqstent or Contour|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy achieving the lack of rebleeding | Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 1 days | 
| Rate of retreatment | Rate of retreatment needed during the follow-up. | 12 months | 
| Rate of mortality during admission or follow-up. | Rate of mortality during admission or follow-up. | 12 months | 
| Functional outcome | Functional outcome at 12 months measured by modified Rankin scale. | 12 months | 
| Rate of vascular thrombosis or acute stroke. | Rate of vascular thrombosis or acute stroke during follow-up. | 12 months | 
| Rate of early rebleeding. | Rate of early rebleeding during the admission. | 30 days. | 
| Rate of complications associated with the procedure. | Rate of complications associated with the procedure. | 1 day |