COMPLEX Post Market Surveillance Electronic Registry

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

Completed

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kobe City General Hospital

Kobe, 650-0046, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endovascular Embolization Device

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

Other names: TRUFILL® DCS and TRUFILL DCS ORBIT Detachable Coils

Primary outcomes

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

Time frame: Between 3-6 months

Secondary outcomes

Adverse events and product complaints

Time frame: Ongoing throughout study

Sponsors and collaborators

Lead sponsor

Codman & Shurtleff

Industry

Registry information

Acronym: COMPLEX

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2009
First posted: Apr 22, 2008
Registry last updated: May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed