ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial
|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: NCT01033214|
Recruitment Status : Unknown
Verified May 2015 by Duke Vascular, Inc..
Recruitment status was: Active, not recruiting
First Posted : December 16, 2009
Last Update Posted : May 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aortic Aneurysm||Device: Endovascular repair of TAA in the descending Thoracic Aorta||Phase 1|
- Subject is > 18 years of age.
- Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
- Subject is a candidate for endovascular thoracic aortic repair.
- Subject has a TAA that meets one of the following criteria:
- Is diagnosed with a Fusiform Focal TAA >5cm, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
- Is diagnosed with a saccular TAA of any size.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||December 2015|
Experimental: TAArget Thoracic Stent Graft
those treated with the investigational device
Device: Endovascular repair of TAA in the descending Thoracic Aorta
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
- Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group. [ Time Frame: 30 day and 6 month ]
- The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events [ Time Frame: 30 day and 6 months ]
- • All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events [ Time Frame: 30 day and 6 month ]
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): NCT01033214
|United States, Delaware|
|Newark, Delaware, United States, 19713|
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kartikeshwar Kasirajan, M.D.||Emory University Medical School|