COMPLEX Post Market Surveillance Electronic Registry

Intracranial Aneurysm Clinical Trial

— COMPLEX  

Official title:

COMPLEX Post Market Surveillance Electronic Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663299
• Other study ID #: 03-2004
• Status: Completed
• Phase: N/A
• First received: April 17, 2008
• Last updated: May 15, 2012
• Start date: June 2004
• Est. completion date: May 2009

Study information

• Verified date: May 2012
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Description:

This Post Market Surveillance Registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial aneurysms treated with the Trufill DCS Orbit detachable platinum coils.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with angiographically documented aneurysms,

2. Either ruptured or unruptured,

3. Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization

Exclusion Criteria:

1) Patient / Treatment outside of the approved labeling, indications for use.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intracranial Aneurysm

Intervention

Device:
• Endovascular 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

Locations

Country	Name	City	State
Japan	Kobe City General Hospital	Kobe

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Hirsch JA, Bendok BR, Paulsen RD, Cognard C, Campos J, Cronqvist M. Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: Trufill DCS Orbit detachable coil system registry interim results. J Vasc Interv Radiol. 2007 Dec;18(12):1487-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms		Between 3-6 months	Yes
Secondary	Adverse events and product complaints		Ongoing throughout study	Yes