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

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Subarachnoid Hemorrhage; Subarachnoid Hemorrhage, Aneurysmal

Treatments: Device: Neqstent or Contour

Study type: Observational

Funder types: Other

Identifiers

NCT05171465

PR(AG)564/2021

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.