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

NCT05171465 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-02-16

No results posted yet for this study

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.

Conditions

  • Subarachnoid Hemorrhage
  • Subarachnoid Hemorrhage, Aneurysmal

Interventions

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.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-03-31
Completion
2024-03-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171465 on ClinicalTrials.gov