Complete Occlusion of Coilable Aneurysms (COCOA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00777907|
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : August 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysm||Device: Pipeline Embolization Device (PED) Device: Coil embolization||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Complete Occlusion of Coilable Aneurysms|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||April 2015|
Active Comparator: Coil embolization
Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed. Stents are not allowed in this arm.
Device: Coil embolization
Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.
Placement of 1 or more Pipeline Embolization Device(s)(PED) into the parent artery at the target aneurysm.
Device: Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.
Other Name: Pipeline Embolization Device, PED
- Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death. [ Time Frame: 180 days ]
- Rate of complete target aneurysm occlusion [ Time Frame: 1, 3 and 5 years ]
- Incidence of ipsilateral major stroke [ Time Frame: 180 days ]
- Change in modified Rankin scale (MRS) [ Time Frame: 180 days, 1, 3 and 5 years ]
- Incidence of device-related adverse events [ Time Frame: 180 days, 1, 3 and 5 years ]
- Change from baseline in neurologic signs or symptoms related to the target aneurysm [ Time Frame: 180 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777907
|United States, Arizona|
|Barrow Neurological Institute|
|Phoenix, Arizona, United States, 85013|
|United States, New York|
|SUNY Stony Brook|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||David Fiorella, MD, PhD||Barrow Neurologic Institute|