WEBCAST: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

• Sponsor: Sequent Medical, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01778322
• Collaborator: (none)
• Enrollment: 51
• Locations: 12
• Duration (Months): 96
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	Procedure: Intracranial aneurysm embolization

Detailed Description

The following parameters will be evaluated as part of this study:

• Aneurysm morphology

• Aneurysm size

• For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)

• Size of the embolization device(s) used in the procedure

• Intra-procedural assessment of aneurysm occlusion and flow stasis

• Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)

• Aneurysm occlusion durability

• Recanalization rate

• Device-related changes in Modified Rankin Scale from baseline

• Complications/adverse events

• Rebleed/new bleed

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Index Embolization Cohort WEB Aneurysm Embolization System	Procedure: Intracranial aneurysm embolization; Treatment of intracranial aneurysms

Outcome Measures

Primary Outcome Measures

1. Durability of occlusion [6 months]

   Evaluated by the Corelab

Secondary Outcome Measures

1. Recurrence/recanalization rate [6 months]

   Evaluated by the Corelab, based on Raymond Roy occlusion scale

2. Modified Raymond Scale [6 months]

   Evaluation of patient's functional level of activity by the physician

3. Percentage occlusion of target aneurysm [6 months]

   Evaluated by the Corelab

Other Outcome Measures

1. Fluoroscopy time [procedure]

   Duration of fluoroscopy time will be recorded during the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be at least 18 years of age

• Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures

Exclusion Criteria:

• Must not have clinical or angiographic evidence of vasospasm

• Must not have lesion with characteristics unsuitable for endovascular treatment

• Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule

• Must not be concurrently involved in another investigational or post-market study

• Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100
2	Hôpital Beaujon	Clichy		France	92118
3	CHU Gui de Chauliac	Montpellier		France	34295
4	CHU Reims Maison Blanche	Reims		France	51092
5	CHU Purpan	Toulouse		France	31059
6	CHU Bretonneau	Tours		France	37000
7	Uniklinik Koeln	Cologne		Germany	50937
8	Helios Klinikum	Erfurt		Germany	99089
9	Klinikum der Johann Wolfgang Goethe Universität	Frankfurt		Germany	60528
10	Klinikum Vest GmbH	Recklinghausen		Germany	45657
11	Klinikum Stuttgart- Katharinenhospital	Stuttgart		Germany	70174
12	National Institute of Neurosciences	Budapest		Hungary	H-1145

Sponsors and Collaborators

• Sequent Medical, Inc

Investigators

• Principal Investigator: Laurent Pierot, MD, CHU Reims

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory).
• Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study.
• Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of Three Prospective, Multicenter Series: 2-Year Follow-up
• Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up

Publications

None provided.

• Responsible Party: Sequent Medical, Inc
• ClinicalTrials.gov Identifier: NCT01778322
• Other Study ID Numbers: CP 11-001
• First Posted: Jan 29, 2013
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

No Results Posted as of Aug 8, 2022