COMPLEX Post Market Surveillance Electronic Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00663299
First received: April 17, 2008
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Intracranial Aneurysm
Device: Endovascular Embolization Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: COMPLEX Post Market Surveillance Electronic Registry

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms [ Time Frame: Between 3-6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events and product complaints [ Time Frame: Ongoing throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 299
Study Start Date: June 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Other Name: TRUFILL® DCS and TRUFILL DCS ORBIT Detachable Coils

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663299

Locations
Japan
Kobe City General Hospital
Kobe, Japan, 650-0046
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Principal Investigator: Bernard Bendok, M.D. Northwestern
  More Information

Publications:
Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00663299     History of Changes
Other Study ID Numbers: 03-2004
Study First Received: April 17, 2008
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Codman & Shurtleff:
Intracranial aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014