370 Participants Needed

Ascending Stent Graft for Aortic Disease

(ARISEII Trial)

Recruiting at 37 trial locations
CS
Overseen ByClinical Study Manager
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The GORE® Ascending Stent Graft is generally considered safe, with a low risk of complications like endoleaks (leakage around the graft) and rare issues such as fistulas (abnormal connections between organs).36789

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

ER

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

Patients with anatomic compatibility with ASG device based on Gore Imaging Sciences review
Patients considered high-risk for open surgical repair
Patients who have signed the Informed Consent Form (ICF)
See 4 more

Exclusion Criteria

I had open chest surgery less than 30 days ago.
I have a new Type A aortic dissection.
I had a complex procedure for heart artery blockage or treatment for a heart attack within the last 30 days.
See 24 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular repair using the ASG device, with or without the TBE device, or open surgical repair

4 weeks

Primary Follow-up

Participants are monitored for primary safety and effectiveness endpoints, including device technical success and absence of reintervention

4 weeks
1 visit (in-person)

Extended Follow-up

Participants are monitored for secondary endpoints, including procedural and treatment success, at multiple follow-up windows

12 months
Multiple visits (in-person) at 6, 12, 24, 36, 48, and 60 months

Treatment Details

Interventions

  • GORE® Ascending Stent Graft
Trial OverviewThe ARISE II trial tests the GORE® Ascending Stent Graft's safety and effectiveness in treating ascending aorta lesions. Participants will receive this stent graft via surgery and their outcomes will be compared to established benchmarks of success.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Surgical Follow-up CohortExperimental Treatment1 Intervention
Open surgical repair of ascending aorta in subjects at high-risk for surgical repair
Group II: ASG device only in Ascending AortaExperimental Treatment1 Intervention
Ascending Aortic Isolated Lesions, Pseudoaneurysms and Penetrating Aortic Ulcers in subjects at high-risk for surgical repair, treated with endovascular repair using the ASG device alone.
Group III: ASG + TBEExperimental Treatment1 Intervention
Ascending Aorta/Aortic Arch Isolated Lesions and Chronic De Novo Dissections in subjects at high-risk for surgical repair, treated with endovascular repair using the ASG and TBE devices.

Find a Clinic Near You

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials
103
Recruited
32,900+

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

Findings from Research

In a study of 6787 patients, different stent-grafts for repairing infrarenal aortic aneurysms showed significant differences in postoperative complications, with AneuRx, Excluder, Talent, and Zenith devices having lower risks of migration, kinking, and occlusion compared to the Vanguard device.
While some devices like AneuRx and Zenith reduced the risk of aneurysm rupture and all-cause mortality, no single stent-graft emerged as the best option, highlighting the need for continued development of improved devices.
Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare?van Marrewijk, CJ., Leurs, LJ., Vallabhaneni, SR., et al.[2016]

References

Back-Table Modified Stent-Graft for Endovascular Repair of Ascending Aorta. [2021]
Outcomes of Endovascular Repair of Ascending Aortic Dissection in Patients Unsuitable for Direct Surgical Repair. [2022]
International experience with endovascular therapy of the ascending aorta with a dedicated endograft. [2017]
Zone zero thoracic endovascular aortic repair: A proposed modification to the classification of landing zones. [2022]
Transapical endovascular repair with a table-tailored endograft to treat ascending aortic dissection. [2022]
Aortoesophageal fistula as a complication of thoracic aorta aneurism stent grafting - a case report and literature review. [2021]
Prosthetic aortic graft replacement of the ascending thoracic aorta alters biomechanics of the native descending aorta as assessed by transthoracic echocardiography. [2022]
Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database. [2022]
Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare? [2016]
Endovascular repair of the ascending aorta: when and how to implement the current technology. [2016]