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

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Rodney A. White, M.D.Lead Sponsor
3 Previous Clinical Trials
368 Total Patients Enrolled
1 Trials studying Aortic Dissection
304 Patients Enrolled for Aortic Dissection
Rodney A White, M.D.Principal InvestigatorLA BioMedical Research Institute at Harbor-UCLA Medical Center
Ali Khoynezhad, M.D. PhD.Principal InvestigatorLA BioMedical Research Institute at Harbor-UCLA Medical Center
~2 spots leftby Dec 2025
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