Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00663299
Other study ID # 03-2004
Secondary ID
Status Completed
Phase N/A
First received April 17, 2008
Last updated May 15, 2012
Start date June 2004
Est. completion date May 2009

Study information

Verified date May 2012
Source Codman & Shurtleff
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardJapan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 299
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Japan Kobe City General Hospital Kobe

Sponsors (1)

Lead Sponsor Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Hirsch JA, Bendok BR, Paulsen RD, Cognard C, Campos J, Cronqvist M. Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: Trufill DCS Orbit detachable coil system registry interim results. J Vasc Interv Radiol. 2007 Dec;18(12):1487-94. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms Between 3-6 months Yes
Secondary Adverse events and product complaints Ongoing throughout study Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04870047 - Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT05665309 - Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor N/A
Completed NCT02783339 - Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Withdrawn NCT01194388 - Axium Coil in Completing Endovascular Aneurysm Surgery Study
Completed NCT00071565 - Familial Intracranial Aneurysm Study II N/A
Recruiting NCT05409989 - MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study N/A
Completed NCT03680742 - Contour Neurovascular System - European Pre-Market Unruptured Aneurysm N/A
Completed NCT04872842 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Terminated NCT02532517 - Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device N/A
Completed NCT03663257 - Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Recruiting NCT06189950 - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE N/A
Recruiting NCT05608122 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
Recruiting NCT03661463 - Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT). Phase 2
Completed NCT02609867 - A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise) N/A
Active, not recruiting NCT02292017 - Prospective Packing Density With Target Coils I N/A
Active, not recruiting NCT01872741 - Minipterional Versus Pterional Craniotomy N/A
Completed NCT00993057 - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia Early Phase 1
Completed NCT00777088 - Pipeline for Uncoilable or Failed Aneurysms N/A
Completed NCT00777907 - Complete Occlusion of Coilable Aneurysms Phase 3