Evaluation of the GORE® Ascending Stent Graft (NCT05800743) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of the GORE® Ascending Stent Graft
United States370 participantsStarted 2023-11-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm
✓. Fusiform aneurysm (≥50mm or documented growth rate \>0.5cm/year)
✓. Saccular aneurysm (no diameter criteria)
✓. Pseudoaneurysms (\>30 days post-surgery, no diameter criteria) Non-aneurysm
✓. Penetrating Aortic Ulcers (PAUs) (no diameter criteria)
✓. Pseudoaneurysms, following open surgical repair of a Type A dissection (\>30 days post-surgery, no diameter criteria)
✓. Anatomic compatibility with ASG device based on Gore Imaging Sciences review.
✓. Treatment must be limited to the ascending aorta
Exclusion criteria
✕. De novo Type A dissection
✕. Requires immediate treatment
✕. Dissected great vessels requiring treatment
✕. Anticipated need for coronary or aortic valve intervention within one year post treatment
✕. Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
What they're measuring
1
Primary effectiveness endpoint as measured by device technical success and absence of reintervention.
Timeframe: 30 Days
2
Primary Safety Endpoint as measured by a composite of the absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, and new onset renal failure requiring permanent dialysis.
✕. Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment
✕. Open chest surgical repair within 30 days prior to treatment
✕. Presence of Intramural Hematoma (IMH) in landing zones