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

Subarachnoid Hemorrhage Clinical Trial

— COVERAGE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05171465
• Other study ID #: PR(AG)564/2021
• Status: Not yet recruiting
• Start date: March 2022
• Est. completion date: March 2024

Study information

• Verified date: December 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Alejandro Tomasello, MD
• Phone: 934893000
• Email: alejandrotomasello[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2024
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

References & Publications (8)

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. Epub 2007 Mar 29. — View Citation

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. — View Citation

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. — View Citation

Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Viñuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. — View Citation

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. Epub 2003 May 29. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy achieving the lack of rebleeding	Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding	12 months
Primary	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
Secondary	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
Secondary	Efficacy achieving the complete occlusion at end of treatment	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
Secondary	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
Secondary	Rate of retreatment	Rate of retreatment needed during the follow-up.	12 months
Secondary	Rate of mortality during admission or follow-up.	Rate of mortality during admission or follow-up.	12 months
Secondary	Functional outcome	Functional outcome at 12 months measured by modified Rankin scale.	12 months
Secondary	Rate of vascular thrombosis or acute stroke.	Rate of vascular thrombosis or acute stroke during follow-up.	12 months
Secondary	Rate of early rebleeding.	Rate of early rebleeding during the admission.	30 days.
Secondary	Rate of complications associated with the procedure.	Rate of complications associated with the procedure.	1 day