Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta

W.L.Gore & Associates

Summary

The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: ASG Device Alone Arm The patient is/has: 1. Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm 1. Fusiform aneurysm (≥50mm or documented growth rate \>0.5cm/year) 2. Saccular aneurysm (no diameter criteria) 3. Pseudoaneurysms (\>30 days post-surgery, no diameter criteria) Non-aneurysm 4. Penetrating Aortic Ulcers (PAUs) (no diameter criteria) 5. Pseudoaneurysms, following open surgical repair of a Type A dissection (\>30 days post-surgery, no d…

Interventions

Device
GORE® Ascending Stent Graft (ASG device)
Endovascular aortic repair of the ascending aorta
Device
GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)
Endovascular aortic repair of the ascending aorta/aortic arch
Procedure
Surgery
Open surgical repair of the ascending aorta and/or the aortic arch

Locations (41)

University of Alabama at Birmingham
Birmingham, Alabama
MemorialCare Heart and Vascular Institute - Long Beach Medical Center
Long Beach, California
Keck Medical Center University of Southern California, HCC II
Los Angeles, California
Cedars Sinai Medical Center
Los Angeles, California
Stanford Hospital
Stanford, California
University of Colorado Hospital Authority
Aurora, Colorado