COMPLEX Post Market Surveillance Electronic Registry

Codman & Shurtleff299 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

299

Conditions

Intracranial Aneurysm

Interventions

Endovascular Embolization DeviceDEVICE

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

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Kobe City General Hospital

Kobe, Japan

Outcomes

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

Data from ClinicalTrials.gov

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