Overview

This trial is active, not recruiting.

Condition intracranial aneurysm
Treatment intracranial aneurysm embolization
Sponsor Sequent Medical, Inc
Start date December 2011
End date December 2015
Trial size 100 participants
Trial identifier NCT01778322, CP 11-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
WEB Aneurysm Embolization System
intracranial aneurysm embolization
Treatment of intracranial aneurysms

Primary Outcomes

Measure
Durability of occlusion
time frame: 6 months

Secondary Outcomes

Measure
Recurrence/recanalization rate
time frame: 6 months
Modified Raymond Scale
time frame: 6 months
Percentage occlusion of target aneurysm
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
Principal investigator Laurent Pierot, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Sequent Medical, Inc.