COMPLEX Post Market Surveillance Electronic Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intracranial Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Trufill Detachable Coil System

There is only one treatment arm in the registry and it is all patients receiving treatment with Trufill Detachable Coil System. The use of bare platinum coils for the endovascular occlusion of cerebral aneurysms.

Group Type OTHER

Endovascular Embolization Device

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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TRUFILL® DCS and TRUFILL DCS ORBIT Detachable Coils

Eligibility Criteria

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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