Zenith® p-Branch™: Single-Center Study (PBCT)
|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: NCT01663064|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2012
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aortic Aneurysm Abdominal Aortic Aneurysm||Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Zenith® p-Branch™: Single-Center Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||July 2020|
Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
- Technical Success [ Time Frame: Up to 5 years ]Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.
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): NCT01663064
|Skane University Hospital|
|Malmo, Sweden, SE-205 02|
|Principal Investigator:||Timothy A. Resch, MD, PhD||Skane University Hospital|