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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment GORE® Ascending Stent Graft for aortic dissection?

Research shows that using stent grafts for repairing the ascending aorta can be a safe and feasible option for patients who cannot undergo open surgery. In a study of high-risk patients, the procedure had low in-hospital mortality and good long-term outcomes, suggesting it could be effective for treating aortic dissection. ^{1 2 3 4 5}

Is the stent graft for aortic dissection generally safe for humans?

The stent graft procedure for aortic dissection is generally considered safe, with a low risk of complications like endoleaks (leakage around the stent), stenosis (narrowing of the blood vessel), or thrombosis (blood clots). Rare complications can occur, such as aortoesophageal and aortobronchial fistulas (abnormal connections between the aorta and other structures), but these are uncommon. ^{5 6 7 8 9}

How is the GORE® Ascending Stent Graft treatment different from other treatments for aortic dissection?

The GORE® Ascending Stent Graft is unique because it is specifically designed for the ascending aorta, unlike many other stent grafts originally made for the descending aorta. This makes it a potential alternative for patients who cannot undergo traditional open surgery for ascending aortic dissection. ^{1 2 3 4 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Back-Table Modified Stent-Graft for Endovascular Repair of Ascending Aorta. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The first endovascular repair of an acute type A dissection using an endograft designed for the ascending aorta. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Endovascular Repair of Ascending Aortic Dissection in Patients Unsuitable for Direct Surgical Repair. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transapical endovascular repair with a table-tailored endograft to treat ascending aortic dissection. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Zone 0 thoracic endovascular aortic repair in high risk patients: A retrospective case series. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Aneurysmal degeneration of the aorta after stent-graft repair of acute aortic dissection. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Mortality within the endovascular treatment in Stanford type B aortic dissections. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

International experience with endovascular therapy of the ascending aorta with a dedicated endograft. [2017]

9. Poland pubmed.ncbi.nlm.nih.gov

Aortoesophageal fistula as a complication of thoracic aorta aneurism stent grafting - a case report and literature review. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Endovascular stent-graft treatment of type A dissection: case report and review of literature. [2022]