COMPLEX Post Market Surveillance Electronic Registry
This study has been completed.
Sponsor:
Codman & Shurtleff
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
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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:
- Patients with angiographically documented aneurysms,
- Either ruptured or unruptured,
- 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 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 May 16, 2013