Stent Graft for Aortic Dissection

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Drug abuse, Connective tissue disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: Procedure duration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stent graft for treating specific types of aortic dissection, a serious condition where the inner layer of the aorta tears. The focus is on the GORE® Ascending Stent Graft to determine its safety and effectiveness for patients with DeBakey Type I/II dissections, where the tear occurs in the part of the aorta closest to the heart. Individuals diagnosed with this specific type of aortic dissection and considered high-risk for surgery might be suitable for the trial. Participants must be able to undergo a CT scan and meet other specific medical criteria to ensure the treatment is appropriate. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to the validation of a potentially life-saving treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to anticoagulants or contrast media, this might affect your eligibility.

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

Research has shown that the GORE® Ascending Stent Graft has been tested for safety in treating aortic dissections, which are serious tears in the heart's main artery. One study found that using a similar stent graft in high-risk patients resulted in an operative mortality rate of 2.33%, indicating that while some risk exists, most patients tolerate the procedure well.

Another study demonstrated the device's effectiveness and safety over five years for treating aortic diseases, highlighting the stent graft's durability and ongoing safety. These findings suggest that although the treatment involves some risk, it offers a promising option for patients with specific heart conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The GORE® Ascending Stent Graft is unique because it offers a new way to treat aortic dissection by providing a minimally invasive option compared to traditional open surgery. Unlike conventional treatments that typically involve complex surgical procedures to repair the aorta, this stent graft can be delivered through a catheter, reducing recovery time and surgical risks. Researchers are excited because this approach could lead to quicker recovery for patients and fewer complications, potentially making it a game-changer for managing aortic dissections.

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

Research has shown that the GORE® Ascending Stent Graft, which participants in this trial will receive, could effectively treat aortic dissections. In similar procedures using endovascular repair, about 96% of cases were completed successfully, meaning the procedure went as planned without major problems. Another study found that the risk of death within 30 days after using endovascular methods for type A aortic dissection was about 17%. This indicates that while risks exist, many people survive the initial treatment. These findings support the potential effectiveness of the GORE® Ascending Stent Graft for aortic dissections. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

An Informed Consent Form signed by Subject or legally authorized representative

I can have a CT scan as needed for planning my procedure.

Exclusion Criteria

Subject has known sensitivities or allergies to the device materials

You have had a bad reaction to heparin in the past.

I am scheduled for heart valve surgery or a procedure to unblock my heart's arteries within the next 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GORE® Ascending Stent Graft for the treatment of DeBakey Type I/II aortic dissections

Procedure duration

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of endoleaks and MACCE

12 months

Multiple visits at 1 month, 6 months, and 12 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• GORE® Ascending Stent Graft

Trial Overview 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.

How Is the Trial Designed?

Group I: GORE® Ascending Stent Graft Experimental Treatment 1 Intervention

Treatment with the GORE® Ascending Stent Graft

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509624008264

Aortic Dissection A Multicenter Clinical Trial on the Five- ... The results of this study indicate that endovascular repair of acute, complicated type B aortic dissections with the GORE CTAG device was durable over the 5- ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11534469/

Long-Term Outcomes of Endovascular Repair of Thoracic ... The Talent Thoracic Stent Graft by Medtronic Vascular showed 5-year freedom from aneurysm-related mortality of 96.1% and freedom from secondary endovascular ...

4. jtcvsstructural.org jtcvsstructural.org/article/S2950-6050(25)00015-4/fulltext

Next frontier in endovascular aortic therapy: An anatomic ... reported 56 patients with type A aortic dissection managed with TEVAR, of which 96% of cases were technically successful. Early operative complications included ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(21)00198-1/fulltext

Systematic review and meta-analysis of endovascular ... The 30-day mortality after endovascular repair of type A aortic dissection was estimated at 17% (95% CI, 10%-26%). The heterogeneity (I2) among ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02380716

ARISE: Evaluation of the GORE® Ascending Stent Graft in ... This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0167527323004710

The efficacy and safety of Gore conformable thoracic stent ... Operative mortality were 2.33% (3 of 129) in the CTAG group and 1.76% (5 of 284) in the Valiant Captivia group. The median follow-up was 41.67 ( ...

8. 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 ...

9. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/ASG-22-02

GORE Ascending Stent Graft in the Treatment of Lesions of ... The purpose of this study is to evaluate the safety and effectiveness of a device called the GORE Ascending Stent Graft (ASG device) to treat aortic disease.