A Phase II Clinical Study of the Safety and Performance of the Treovance Stent Graft with Navitel Delivery System for Patients with Infrarenal Abdominal Aortic Aneurysms
ID Number 14-0561Principal Investigator(s)
Sung Yup Kim
Department(s) or Division(s)
This study will be conducted in order to evaluate the safety and performance of the Treovance Stent-Graft with Navitel Delivery System device. This device has yet to be FDA-approved and will be entering its 2nd phase of assessment. The study will be conducted using a maximum of 150 patients from a total of 30 sites all across the United States, including The Mount Sinai Hospital, who have been diagnosed with an infrarenal abdominal aortic aneurysm (AAA). For eligible patients who are screened and enrolled in the study, the patient will undergo a surgical procedure for device placement. Post-operative follow-up visits will occur at 1 month, 6 months, and 12 months. The patient will also come back to the hospital once per year for up to 5 years. The follow-up visits will include the completion of clinical assessments and questionnaires.
Recruiting Patients: Yes