Ascending Stent Graft for Aortic Disease

(ARISEII Trial)

Enrolling by invitation at 42 trial locations

Overseen By Clinical Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must not be taking: Dual antiplatelet therapy

Disqualifiers: Acute dissection, Coronary intervention, Stroke, Connective tissue disease, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the GORE® Ascending Stent Graft, a device designed to safely and effectively treat issues in the ascending aorta and aortic arch, such as aneurysms or ulcers. The trial explores different approaches, including using the stent graft alone or with an additional device, particularly for those at high risk of complications from traditional surgery. Suitable candidates may have conditions like aortic aneurysms or ulcers, have undergone previous surgery, and are considered high-risk for further surgery. As an unphased trial, this study provides patients with access to innovative treatment options that may not be available through standard care.

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 prior data suggests that the GORE® Ascending Stent Graft device is safe for treating aortic disease?

Previous studies have found the GORE® Ascending Stent Graft to be generally safe and well-tolerated. It has been effectively used for patients with serious aortic conditions. Research has shown promising results, with no major unexpected safety issues reported.

When combined with the TBE device, studies also show positive safety results. This combination has effectively treated complex aortic problems. Patients usually experience good outcomes, and the safety remains consistent with earlier studies.

Overall, both treatments have demonstrated encouraging safety data in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard surgical repair for aortic conditions, the GORE® Ascending Stent Graft (ASG) offers a minimally invasive option that could benefit patients at high risk for surgery. This treatment is unique because it uses endovascular repair, allowing the stent graft to be placed via a catheter, reducing the need for open-chest surgery. Researchers are excited because this method can potentially lower recovery time and decrease complications associated with traditional surgery. Additionally, the ASG can be used alone or in combination with the TBE device, offering flexibility to address complex aortic lesions and dissections more effectively.

What evidence suggests that the GORE® Ascending Stent Graft device is effective for aortic disease?

Research has shown that the GORE® Ascending Stent Graft effectively treats issues in the upper aorta, the body's main artery. In this trial, participants may receive the ASG device alone, which studies have found beneficial for patients at high risk for traditional surgery by offering a less invasive option. Previous evaluations of similar treatments, which operate inside the blood vessel, have demonstrated positive outcomes for conditions like pseudoaneurysms and small aortic ulcers. Additionally, some participants will receive the GORE® Ascending Stent Graft with the TBE device, which early findings suggest may effectively treat chronic aortic dissections. These devices provide promising alternatives to more invasive surgeries. ^{1 2 4 6 7}

Who Is on the Research Team?

Eric Roselli, M. D.

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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)

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• GORE® Ascending Stent Graft

Trial Overview The 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.

How Is the Trial Designed?

Group I: Surgical Follow-up Cohort Experimental Treatment 1 Intervention

Open surgical repair of ascending aorta in subjects at high-risk for surgical repair

Group II: ASG device only in Ascending Aorta Experimental Treatment 1 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 + TBE Experimental Treatment 1 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.

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

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05800743

Evaluation of the GORE® Ascending Stent Graft (ARISEII) 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 ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20561752

Evaluation Of The GORE® Ascending Stent Graft The purpose of this study is to assess the safety and effectiveness of the GORE® Ascending Stent Graft (ASG) device in the treatment of lesions ...

3. withpower.com withpower.com/trial/phase-aneurysm-9-2023-721dc

Ascending Stent Graft for Aortic Disease (ARISEII 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522436/

Minimally Invasive Endovascular Repair for Nondissected ... The aim of this study is to evaluate the efficacy of endovascular treatment for nondissected diseases of the ascending aorta.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0741521420322783

Outcomes of endovascular stent graft repair for penetrating ... We investigated the outcomes of endovascular repair for penetrating aortic ulcers (PAUs) with and without intramural hematoma (IMH).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10022529/

Endovascular Management of the Ascending Aorta This study examined the use of a specifically designed stent graft in high-risk patients presenting with acute type A aortic dissection and ...

7. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/arise-ii-underway-to-evaluate-ascending-aorta-stent-graft-for-endovascular-repair

Novel Ascending Aorta Stent Graft for Endovascular Repair The device studied in both ARISE trials is the GORE® ASG (Ascending Stent Graft) ... Study finds comparable midterm safety outcomes, suggesting ...