What side effects are associated with this type of intervention?

Common side effects of endovascular repair for aortic dissection, such as the Medtronic Valiant PS-IDE Stent Graft, include endoleak, device migration, stent graft infolding or collapse, and potential rupture of the treated aneurysm. Serious complications can include aortoesophageal fistula and cerebral embolization, which may result in silent cerebral infarctions and neurocognitive decline. Coverage of the left subclavian artery during the procedure can also lead to ischemia and functional impairment of the left arm.

What prior FDA approvals exist?

The FDA has approved several endovascular stent grafts for the treatment of aortic dissection, which function similarly to the Medtronic Valiant PS-IDE Stent Graft by rerouting blood to the true lumen and covering the proximal tear in the aorta. Notable examples include the GORE TAG Thoracic Branch Endoprosthesis, which is designed for the thoracic aorta and has been used to treat various aortic pathologies, including dissections. These devices are typically made from materials like Nitinol wire and polyester, providing a durable and flexible solution for managing aortic dissections and preventing rupture.

What other types of research exist?

Promising novel alternatives to the Medtronic Valiant PS-IDE Stent Graft for aortic dissection patients include: 1) The use of thoracic endovascular aortic repair (TEVAR) with distal bare-metal stents, which has shown improved remodeling and outcomes in the ASSIST study. 2) The Cook Zenith Dissection Endovascular System, designed specifically for treating aortic dissections by providing true lumen support and false lumen exclusion. 3) The Gore TAG Conformable Thoracic Stent Graft, which offers flexibility and conformability to better adapt to the aortic anatomy and cover tears effectively.

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Stent Graft

Endovascular Stent Graft for Aortic Dissection

N/A

Recruiting

Led By Rodney A White, M.D.

Research Sponsored by Rodney A. White, M.D.

Eligibility Criteria Checklist

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

Must have

Patient must also have at least one cm proximal and distal landing zones in the ascending aorta between 28-44 mm in diameter

Patient must have a Type A thoracic aortic dissection, retrograde Type A thoracic aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered candidates for endovascular repair

Must not have

Pregnant or pediatric patients (younger than 21 years of age)

Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special tube-like device called a stent graft to fix serious problems in the large artery near the heart. It targets patients with specific conditions that can lead to life-threatening complications. The stent graft helps by covering damaged areas and ensuring blood flows correctly. Stent grafts have been iteratively developed and are used to treat various arterial conditions by providing vessel support and ensuring proper blood flow.

Who is the study for?

This trial is for adults with specific aortic conditions like Type A thoracic aortic dissection and similar issues, who are high-risk surgical candidates but can undergo endovascular repair. It excludes pregnant individuals, those under 21, patients not expected to live more than a year, or with allergies to stent materials.

What is being tested?

The study tests the Medtronic Valiant PS-IDE Stent Graft's effectiveness in repairing ascending thoracic aorta pathologies. The device has been used for type B dissections and may work similarly for type A by rerouting blood flow.

What are the potential side effects?

Potential side effects might include complications related to the stent graft placement such as infection, allergic reactions to materials, or issues arising from improper blood flow redirection.

Eligibility Criteria

Inclusion Criteria

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

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My aorta is the right size for the procedure.

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I have a specific type of aortic dissection or related condition and am a candidate for a less invasive repair.

Exclusion Criteria

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

Select...

I am not pregnant and I am 21 years old or older.

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I am at risk of an infection in my heart valve or stent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and to 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromise

Secondary study objectives

A composite of successful delivery and deployment of stent graft, coverage of lesion and/or proximal entry tear, aortic remodeling based on serial imaging, rupture

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: Endovascular repair of ascending aortaExperimental Treatment1 Intervention

Endovascular repair with Valiant PS-IDE Stent Graft

0 / 4Eligibility 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 treatment for aortic dissection, particularly in the context of the Medtronic Valiant PS-IDE Stent Graft, involves the use of endovascular stent grafts. These devices work by rerouting blood flow to the true lumen of the aorta, effectively covering the proximal tear and preventing further blood from entering the false lumen. This stabilization of the aortic wall reduces the risk of rupture and promotes healing. For patients, this approach is less invasive compared to open surgery, offers quicker recovery times, and is crucial in preventing life-threatening complications associated with aortic dissection.