Ascending Stent Graft for Aortic Disease
(ARISEII Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had certain heart procedures or treatments requiring specific medications like Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment, you may not be eligible to participate.
What data supports the effectiveness of the GORE® Ascending Stent Graft treatment for aortic disease?
Research shows that stent grafts, like the GORE® Ascending Stent Graft, are a promising option for patients with aortic disease who cannot undergo traditional surgery. Studies have demonstrated the safety and feasibility of using stent grafts in the ascending aorta, suggesting they can be an effective alternative treatment.12345
Is the GORE® Ascending Stent Graft generally safe for humans?
How is the GORE® Ascending Stent Graft treatment different from other treatments for aortic disease?
The GORE® Ascending Stent Graft is unique because it is specifically designed for the ascending aorta, offering a minimally invasive alternative for patients who are high-risk or unsuitable for traditional surgery. This treatment uses a stent graft (a tube-like device) to reinforce the aorta, which can be particularly beneficial for those who cannot undergo direct surgical repair.123410
Research Team
Eric Roselli, M. D.
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
This trial is for adults over 18 with certain aortic conditions needing repair, who can handle a transfemoral or retroperitoneal approach and agree to a 5-year follow-up. It's not for those with acute dissections, recent heart surgeries, severe kidney failure, short life expectancy, allergies to device materials or contrast media, or pregnant women.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo endovascular repair using the ASG device, with or without the TBE device, or open surgical repair
Primary Follow-up
Participants are monitored for primary safety and effectiveness endpoints, including device technical success and absence of reintervention
Extended Follow-up
Participants are monitored for secondary endpoints, including procedural and treatment success, at multiple follow-up windows
Treatment Details
Interventions
- GORE® Ascending Stent Graft
Find a Clinic Near You
Who Is Running the Clinical Trial?
W.L.Gore & Associates
Lead Sponsor
Bret Snyder
W.L.Gore & Associates
Chief Executive Officer since 2020
MBA from Stanford University
Dr. John Doe
W.L.Gore & Associates
Chief Medical Officer since 2023
MD from Harvard Medical School