The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
|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: NCT02048514|
Recruitment Status : Unknown
Verified January 2014 by Endologix.
Recruitment status was: Active, not recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysms||Device: The Nellix® EndoVascular Aneurysm Sealing System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
Experimental: Nellix Aneurysm Sealing
The Nellix® EndoVascular Aneurysm Sealing System
Device: The Nellix® EndoVascular Aneurysm Sealing System
- Safety [ Time Frame: 30 day ]The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.
- Device Performance [ Time Frame: 30 days ]The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.
- All Cause Mortality [ Time Frame: 12 months ]Any death occurring during the study period, regardless of cause
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): NCT02048514
|Centro Medico de Cali|
|Cali, Colombia, 24-157|
|Paul Stradins University Hospital|
|Riga, Latvia, LV-1007|
|Auckland City Hospital|
|Auckland, New Zealand, 1142|
|Instituto de Clinicas Y Urologica Tomanaco|