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Sponsored by: |
Codman & Shurtleff |
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Information provided by: | Codman & Shurtleff |
ClinicalTrials.gov Identifier: | NCT00663299 |
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
Condition | Intervention |
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Wide-Neck Intracranial Aneurysm |
Device: TRUFILL® DCS and TRUFILL DCS ORBIT (Artificial Embolization Device) |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | COMPLEX Post Market Surveillance Electronic Registry |
Estimated Enrollment: | 500 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Endosaccular packing of intracranial aneurysms
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Device: TRUFILL® DCS and TRUFILL DCS ORBIT (Artificial Embolization Device)
The TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils are each an embolic coil system that consists of a platinum detachable coil, a delivery system (delivery tube and coil introducer) and a syringe. Each system has been designed to deliver, position and detach embolic coils in order to embolize intracranial aneurysms
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: H. Wayne Hutman, MD | 908-412-3871 | hhutman@crdus.jnj.com |
Japan | |
Kobe City General Hospital | Recruiting |
Kobe, Japan, 650-0046 | |
Contact: Nobuyuki Sakai, MD PhD |
Responsible Party: | Cordis ( H. Wayne Hutman, MD / Director ) |
Study ID Numbers: | 03-2004 |
Study First Received: | April 17, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00663299 |
Health Authority: | United States: Institutional Review Board; Japan: Ministry of Health, Labor and Welfare |
Intracranial aneurysm |
Intracranial Aneurysm Aneurysm Vascular Diseases Central Nervous System Diseases |
Brain Diseases Cerebrovascular Disorders Intracranial Arterial Diseases |
Nervous System Diseases Cardiovascular Diseases |