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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03033043
Study type Interventional
Source Bolton Medical
Contact
Status Active, not recruiting
Phase N/A
Start date December 14, 2017
Completion date October 2026

See also
  Status Clinical Trial Phase
Completed NCT04918212 - Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection N/A
Not yet recruiting NCT05874206 - CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions N/A
Active, not recruiting NCT03033771 - Dragon Study Europe N/A
Enrolling by invitation NCT02726841 - Hybrid Treatment of Type B Aortic Dissection N/A
Recruiting NCT03001739 - Intensive Blood PRessure Control in Patients With Acute Type B AortIc Dissection Phase 1