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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neqstent or Contour | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy achieving the lack of rebleeding | Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding | 12 months |
| Efficacy achieving the complete occlusion | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the primary outcomes in different subgroups | Analysis of the primary outcomes in different subgroups: anterior versus vertebrobasilar circulation, narrow versus wide (≥4mm) neck, aneurysm size (<10mm versus ≥10mm). | 12 months |
| Efficacy achieving the complete occlusion at end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Tomasello, MD | Contact | 934893000 | 6748 | alejandrotomasello@gmail.com |
| Manuel Requena, MD PhD | Contact | 934893000 | 6748 | mrequena@vhebron.net |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16139655 | Background | Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5. | |
| 19329361 |
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Under reasoned request for metaanalysis or pooled data analysis
From now to the end of the study
Under reasoned request for metaanalysis or pooled data analysis
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at end of treatment. |
| 1 day |
| Rate of patients who underwent the study treatment. | Rate of patients who were included in the study and finally underwent the study treatment. | 1 days |
| Rate of retreatment | Rate of retreatment needed during the follow-up. | 12 months |
| Rate of mortality during admission or follow-up. | Rate of mortality during admission or follow-up. | 12 months |
| Functional outcome | Functional outcome at 12 months measured by modified Rankin scale. | 12 months |
| Rate of vascular thrombosis or acute stroke. | Rate of vascular thrombosis or acute stroke during follow-up. | 12 months |
| Rate of early rebleeding. | Rate of early rebleeding during the admission. | 30 days. |
| Rate of complications associated with the procedure. | Rate of complications associated with the procedure. | 1 day |
| Background |
| Molyneux AJ, Kerr RS, Birks J, Ramzi N, Yarnold J, Sneade M, Rischmiller J; ISAT Collaborators. Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long-term follow-up. Lancet Neurol. 2009 May;8(5):427-33. doi: 10.1016/S1474-4422(09)70080-8. Epub 2009 Mar 28. |
| 12744354 | Background | Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Vinuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. doi: 10.3171/jns.2003.98.5.0959. |
| 12775880 | Background | Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. doi: 10.1161/01.STR.0000073841.88563.E9. Epub 2003 May 29. |
| 26115467 | Background | Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Russin JJ, Partovi S, Nakaji P, Wallace RC. The Barrow Ruptured Aneurysm Trial: 6-year results. J Neurosurg. 2015 Sep;123(3):609-17. doi: 10.3171/2014.9.JNS141749. Epub 2015 Jun 26. |
| 30849758 | Background | Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Nakaji P, Karis JP, Wallace RC. Ten-year analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial. J Neurosurg. 2019 Mar 8;132(3):771-776. doi: 10.3171/2018.8.JNS181846. Print 2020 Mar 1. |
| 17395870 | Background | Campi A, Ramzi N, Molyneux AJ, Summers PE, Kerr RS, Sneade M, Yarnold JA, Rischmiller J, Byrne JV. Retreatment of ruptured cerebral aneurysms in patients randomized by coiling or clipping in the International Subarachnoid Aneurysm Trial (ISAT). Stroke. 2007 May;38(5):1538-44. doi: 10.1161/STROKEAHA.106.466987. Epub 2007 Mar 29. |
| 32719167 | Background | Youssef PP, Dornbos Iii D, Peterson J, Sweid A, Zakeri A, Nimjee SM, Jabbour P, Arthur AS. Woven EndoBridge (WEB) device in the treatment of ruptured aneurysms. J Neurointerv Surg. 2021 May;13(5):443-446. doi: 10.1136/neurintsurg-2020-016405. Epub 2020 Jul 21. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |