COMPLEX Post Market Surveillance Electronic Registry

Codman & Shurtleff

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: Endovascular Embolization Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663299

03-2004

Details and patient eligibility

About

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

Full 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.

Enrollment: 299 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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299 participants in 1 patient group

Trufill Detachable Coil System

Other group

Description:

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.

Treatment:

Device: Endovascular Embolization Device