A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
A prospective, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and performance of the TriVascular AAA Stent Graft when used in the treatment of patients with Abdominal Aortic Aneurysms (AAA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Single occurrence permanent implant of AAA device.
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, Germany
Univeristy Klinik Köln
Cologne, Germany
Klinikum Dortmund GmbH
Dortmund, Germany
Cardiovascular Center Frankfurt-Sankt Katherinen
Frankfurt, Germany
The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure.
The safety of the TriVascular AAA Stent Graft will be determined by comparing the rate of Serious Adverse Events in the Treatment Group against the rate of Serious Adverse Events in the Control Group within 30 days of the initial procedure.
Time frame: 30-Days
To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure.
The performance of the TriVascular AAA Stent-Graft System will be determined by comparing the composite success rate in the Treatment Group against an estimated success rate of 80% in the Control Group within 30 days of the initial procedure. The composite success rate is defined as: 1. Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. 2. Absence of Type I and III endoleaks 3. Absence of Rupture 4. Absence of Conversion to Open Surgical Repair 5. Freedom from mortality
Time frame: 30-Days
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Universitäres Herz und Gefäß Zentrum Hamburg
Hamburg, Germany
Herzzentrum Leipzig
Leipzig, Germany
St Franziskus Hospital Munster
Münster, Germany