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

• Conditions: Subarachnoid Hemorrhage, Aneurysmal; Subarachnoid Hemorrhage

• Registration Number: NCT05171465
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-29
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-16
• Study Start: 2022-03
• Primary Completion: 2022-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy achieving the lack of rebleeding	12 months	Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding
Efficacy achieving the complete occlusion	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Rate of mortality during admission or follow-up.	12 months	Rate of mortality during admission or follow-up.
Analysis of the primary outcomes in different subgroups	12 months	Analysis of the primary outcomes in different subgroups: anterior versus vertebrobasilar circulation, narrow versus wide (≥4mm) neck, aneurysm size (\<10mm versus ≥10mm).
Efficacy achieving the complete occlusion at end of treatment	1 day	Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at end of treatment.
Rate of patients who underwent the study treatment.	1 days	Rate of patients who were included in the study and finally underwent the study treatment.
Rate of retreatment	12 months	Rate of retreatment needed during the follow-up.
Functional outcome	12 months	Functional outcome at 12 months measured by modified Rankin scale.
Rate of vascular thrombosis or acute stroke.	12 months	Rate of vascular thrombosis or acute stroke during follow-up.
Rate of early rebleeding.	30 days.	Rate of early rebleeding during the admission.
Rate of complications associated with the procedure.	1 day	Rate of complications associated with the procedure.