COMPLEX Post Market Surveillance Electronic Registry

This study is currently recruiting participants.

Verified by Codman & Shurtleff, January 2009

First Received: April 17, 2008 Last Updated: January 5, 2009 History of Changes

Sponsored by:	Codman & Shurtleff
Information provided by:	Codman & Shurtleff
ClinicalTrials.gov Identifier:	NCT00663299

Purpose

To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.

Condition	Intervention
Wide-Neck Intracranial Aneurysm	Device: TRUFILL® DCS and TRUFILL DCS ORBIT (Artificial Embolization Device)

MedlinePlus related topics: Aneurysms Brain Aneurysm

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

Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:

To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms [ Time Frame: Between 3-6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events and product complaints [ Time Frame: Ongoing throughout study ] [ Designated as safety issue: Yes ]

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
1 Endosaccular packing of intracranial aneurysms	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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with angiographically documented aneurysms, either ruptured or unruptured, who are deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663299

Contacts

Contact: H. Wayne Hutman, MD

908-412-3871

Locations

Japan
Kobe City General Hospital	Recruiting
Kobe, Japan, 650-0046
Contact: Nobuyuki Sakai, MD PhD

Sponsors and Collaborators

Codman & Shurtleff

More Information

Publications:

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 History of Changes
Health Authority:	United States: Institutional Review Board; Japan: Ministry of Health, Labor and Welfare

Keywords provided by Codman & Shurtleff:

Intracranial aneurysm

Study placed in the following topic categories:

Intracranial Aneurysm
Aneurysm
Vascular Diseases
Central Nervous System Diseases

Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases

Additional relevant MeSH terms:

Intracranial Aneurysm
Aneurysm
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on May 07, 2009