Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal
Conditions
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.
Interventions
DEVICENeqstent 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
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| Functional outcome | 12 months | Functional outcome at 12 months measured by modified Rankin scale. |
| 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. |
Contacts
Primary ContactAlejandro Tomasello, MD
Backup ContactManuel Requena, MD PhD
Outcome results
None listed