What side effects are associated with this type of intervention?

Common side effects of treatments for aortic dissection, such as the GORE® Ascending Stent Graft, include endoleak, device migration, stent-graft infolding or collapse, and retrograde aortic dissection. Patients may also experience pleural effusions. Rare but serious complications can include rupture of the treated aneurysm and stent-graft erosion into adjacent structures like the esophagus.

What prior FDA approvals exist?

The FDA has approved several endovascular stent grafts for the treatment of aortic dissection, which work by reinforcing the weakened section of the aorta to prevent further dissection or rupture. Notable examples include the GORE TAG Thoracic Endoprosthesis and the Medtronic Valiant Thoracic Stent Graft. These devices are designed to provide a minimally invasive alternative to open surgical repair, offering a viable option for patients with thoracic aortic aneurysms and dissections.

What other types of research exist?

Promising novel alternatives to the GORE® Ascending Stent Graft for aortic dissection patients include next-generation stent grafts designed specifically for ascending and arch aortic lesions. These new designs focus on improved flexibility, accurate deployment, and enhanced fixation systems to better manage challenging aortic anatomies. Additionally, advancements in endograft technology aim to provide better radial support and adaptability to changes in aneurysm configuration over time, potentially offering improved outcomes for patients.

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Stent Graft

Stent Graft for Aortic Dissection

N/A

Waitlist Available

Research Sponsored by W.L.Gore & Associates

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia

Adequate vascular access via transfemoral or retroperitoneal approach

Must not have

Previous thoracic aortic surgery

Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 6 months, and 12 months post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with serious tears in their aorta using a special tube called the GORE® Ascending Stent Graft. This device helps to support and repair the damaged blood vessel. The goal is to see if this treatment is safe and effective for these patients. The GORE® Ascending Stent Graft has been used in high-risk patients for various aortic diseases, showing promising results over time.

Who is the study for?

This trial is for individuals at high surgical risk with DeBakey Type I/II aortic dissection who can follow the study's protocol and undergo CT scans. They must have an aorta size compatible with the GORE® Stent Graft, and not require certain heart procedures within 30 days. Exclusions include drug abuse history, pregnancy, allergies to device materials, previous thoracic surgery, connective tissue diseases, poor imaging due to body habitus or conditions preventing clear visualization of the aorta.

What is being tested?

The ARISE trial is evaluating how well the GORE® Ascending Stent Graft works in treating DeBakey Type I/II aortic dissections. This involves placing a stent graft within the ascending part of the aorta where there's been separation (dissection) between layers of its wall.

What are the potential side effects?

While specific side effects are not listed here, similar procedures may involve risks like bleeding, infection at access sites, allergic reactions to materials or contrast media used during implantation and potential complications related to placement such as movement or damage to surrounding structures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My aortic tear starts beyond 2cm from where the heart's arteries begin.

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I can have procedures done through my groin or belly area.

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My aortic dissection type fits the treatment with GORE® Stent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on the aorta in my chest.

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My aortic tear starts in the upper part of my aorta and blood flows backward.

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I have an infection that could risk a graft infection.

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I have a condition like Marfan's or Ehler-Danlos Syndrome.

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I have severe aortic valve leakage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 6 months, and 12 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 6 months, and 12 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 6 months, and 12 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All Cause Mortality at 30 Days Post-procedure

Secondary study objectives

Aorta-related Mortality

Endoleak Assessed Through 1 Month, 6 Months, and 12 Months

Individual MACCE Components Through 30 Days, 6 Months, and 12 Months

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GORE® Ascending Stent GraftExperimental Treatment1 Intervention

Treatment with the GORE® Ascending Stent Graft

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for aortic dissection include endovascular stent grafting, surgical repair, and medical management. The GORE® Ascending Stent Graft, for example, works by reinforcing the weakened section of the aorta, thereby preventing further dissection or rupture. This is crucial for patients as it stabilizes the aorta and reduces the risk of life-threatening complications. Surgical repair involves removing the dissected section and replacing it with a synthetic graft, which is essential for immediate stabilization in acute cases. Medical management typically includes blood pressure control to reduce stress on the aortic wall, which helps prevent the progression of the dissection. These treatments are vital as they address both the structural integrity of the aorta and the underlying risk factors, thereby improving patient outcomes and survival rates.