Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2014 by Microvention-Terumo, Inc.
Sponsor:
Microvention-Terumo, Inc.
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01801007
First received: February 26, 2013
Last updated: June 27, 2014
Last verified: June 2014
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Purpose
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
| Condition | Intervention | Phase |
|---|---|---|
|
Intracranial Aneurysms |
Device: Flow Re-Direction Endoluminal Device |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms |
Resource links provided by NLM:
Further study details as provided by Microvention-Terumo, Inc.:
Primary Outcome Measures:
- Proportion of subjects who experience neurological death or major ipsilateral stroke measured by the modified Rankin Scale(mRS)and the National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- Proportion of subjects with complete occlusion of the target aneurysm and ≤50% stenosis of the parent artery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 127 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Flow Re-Direction Endoluminal Device | Device: Flow Re-Direction Endoluminal Device |
Eligibility| Ages Eligible for Study: | 22 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject whose age≥ 22and ≤75 years
- Subject has single target aneurysm located in the internal carotid artery
- Subject fulfills study requirements and his/her legally authorized representative provides a signed informed consent form
Exclusion Criteria:
- Subject who suffers from an intracranial hemorrhage in the last 30 days
- Subject who suffers from a subarachnoid hemorrhage in the last 60 days
- Subject with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and nexk region
- Subject who is pregnant or breastfeeding
- Subject has an arteriovenous malformation (AVM)in the area of the target aneurysm
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801007
Show 22 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801007
Contacts
| Contact: Vinny Podichetty | 7142478043 | vinny.podichetty@microvention.com |
Show 22 Study Locations
Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
| Principal Investigator: | Cameron McDougall, MD | Barrow Neurological Institute |
More Information
No publications provided
| Responsible Party: | Microvention-Terumo, Inc. |
| ClinicalTrials.gov Identifier: | NCT01801007 History of Changes |
| Other Study ID Numbers: | CL12001, G120111 |
| Study First Received: | February 26, 2013 |
| Last Updated: | June 27, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases |
Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015