Share on facebook Share on Twitter Share on Google Plus Share This
Back to Results

PRO-A Thoracic Stent-Graft Sytem


Title A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Therapeutic Area Aortic Aneurysm, Atherosclerotic Ulcers, Stent-Grafts
Principal Investigator Payem Salehi, MD
Min Age 18 Years
Gender All
Contact Kaytie Beasley
617 636-5287
More Information https://clinicaltrials.gov/ct2/show/NCT02818972

Overview

The purpose of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with aneurysms and Penetrating Atherosclerotic Ulcers (PAUs) within the descending thoracic area.

Study Details

Inclusion Criteria

  • Subject has any of the following conditions in his/her descending thoracic aorta
    • Aneurysm >= 5.0 cm in diameter
    • Aneurysm >= 4.0 cm in diameter with an increase of >= 0.5 cm within the last 6 months or >=1.0 cm over the last 12 months
    • Aneurysm with maximum diameter exceeding two times the diameter of the non-aneurysmal, adjacent aorta
    • Saccular aneurysm
    • PAU within the DTA with a depth of 10 mm or more
  • Proximal and distal aortic neck with diameter between 18 mm and 42 mm
  • Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery. The length of the attachment zones will depend on the intended stent graft diameter and type of graft selected.

Exclusion Criteria

  • Acute or chronic aortic dissection within the ascending aorta, arch or descending thoracic
  • Intramural hematoma (current or previous)
  • Traumatic aortic injury or transection

Study Requirements

Subjects will be followed for one year. A CT scan with contrast is required at the screening, 1 month, 6 month, and 12 month appointments (if unable to do a CT with contrast, MRI or ultrasound combined with unenhanced CT may be performed). CT without contrast will be performed at 1 month, 6 month, and 12 month appointments. Chest X-Ray will be performed at 1 month, 6 month, and 12 month appointments. Angiogram will be performed on treatment day. Treatment may be endoscopic or open procedure. There are 5 total visits (screening, treatment, 1 month, 6 month, 12 month) but there could be unscheduled/unplanned appointments per physicians discretion.