Clinical trial NCT05171465: Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE
Official title: Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVERAGE study is a multicentric and international study developed in high volume centers with previous experienced using intrasaccular neck occlusion devices.

Patients that met all eligibility criteria are considered for enrolment. We include patients with SAH due to a ruptured intracranial saccular aneurysm and mild to moderate clinical symptoms (World Federation Neurological Surgeons ≤ III).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy achieving the lack of rebleeding
timeFrame: 12 months
measure: Efficacy achieving the complete occlusion
timeFrame: 12 months
Secondary outcomes:
measure: Analysis of the primary outcomes in different subgroups
timeFrame: 12 months
measure: Efficacy achieving the complete occlusion at end of treatment
timeFrame: 1 day
measure: Rate of patients who underwent the study treatment.
timeFrame: 1 days
measure: Rate of retreatment
timeFrame: 12 months
measure: Rate of mortality during admission or follow-up.
timeFrame: 12 months
measure: Functional outcome
timeFrame: 12 months
measure: Rate of vascular thrombosis or acute stroke.
timeFrame: 12 months
measure: Rate of early rebleeding.
timeFrame: 30 days.
measure: Rate of complications associated with the procedure.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
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