This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure. Subjects will be enrolled on a first come, first serve basis; however, no single investigational site may enroll more than 20% of the proposed sample size of up to 80 subjects. A subject is considered enrolled when arterial access is gained and an attempt is made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in mid-2016 and complete by the end of 2020. All subjects enrolled, as defined above, will be included in the patient population for the primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the primary effectiveness analyses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Endovascular treatment of an aortic dissection
USC Department of Surgery
Los Angeles, California, United States
All-cause mortality post-procedure
All-cause mortality 30 days post-procedure
Time frame: 30 days
Technical Success at the time of the index procedure
Successful delivery and deployment of the device, including withdrawal of the delivery system;
Time frame: During deployment of the device
Treatment success through 1 month
* Absence of Major adverse Event (MAE) * Absence of relevant MAEs: * Paraplegia; * Paraparesis; * New ischemia due to branch vessel compromise; * Absence of unintentional rupture of the dissection septum;
Time frame: 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
Dissection Treatment Success
• Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
Time frame: 1, 6, and 12 month follow-up visits, and annually through 5 years.
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