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Stent Graft

Endovascular Repair for Thoracoabdominal Aortic Aneurysm

N/A

Waitlist Available

Research Sponsored by Matthew Eagleton

Eligibility Criteria Checklist

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

Must have

Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm

Proximal landing zone for the thoracic bifurcation stent graft that has: ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) and a diameter in the range of 26-42 mm

Must not have

Patient has a contained rupture

Thrombus or excessive calcification within the proximal aortic neck

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each follow-up interval (five years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device to treat thoracoabdominal aortic aneurysms. The primary goal is to assess safety and preliminary effectiveness.

Who is the study for?

This trial is for adults with thoracoabdominal aortic aneurysms that have grown or are symptomatic. Candidates should have specific measurements in their arteries to fit the stent graft and must not be good candidates for open surgery or other treatments. They need at least a year's life expectancy, compatible vessel morphology, and willingness to follow up.

What is being tested?

The Valiant Thoracoabdominal Stent Graft System is being tested for safety and effectiveness in repairing thoracoabdominal aortic aneurysms. The study will evaluate how well it works immediately after placement and over time during follow-up checks.

What are the potential side effects?

Potential side effects may include risks related to endovascular procedures such as blood vessel damage, infection risk from the procedure, allergic reactions to materials in the stent graft system, or complications like blockage of blood flow.

Eligibility Criteria

Inclusion Criteria

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

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My artery or graft site for fixation is the right size and length.

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My aorta near the left shoulder has a healthy section for a stent and is 26-42 mm wide.

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I am 18 years old or older.

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My aneurysm grew more than 0.5 cm in 6 months.

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My aneurysm is at high risk of bursting.

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I have a large aneurysm causing symptoms.

Exclusion Criteria

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

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I have a contained rupture.

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I have a blood clot or severe hardening in the upper part of my aorta.

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My anatomy allows for at least one open hypogastric artery.

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I have a blood clotting disorder that cannot be corrected.

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I have unstable chest pain.

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My anatomy prevents proper blood flow in my left subclavian artery.

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I have a tear in the main artery intended for treatment.

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I have had a procedure to open blocked arteries in my abdomen.

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I have had a ruptured aneurysm.

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I am allergic or react badly to blood thinners or contrast dyes that can't be managed with medication.

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I had surgery to repair an aneurysm and may need a new procedure that goes beyond the previous repair area.

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My health is very poor, with major issues in two body systems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at each follow-up interval (five years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at each follow-up interval (five years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at each follow-up interval (five years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Freedom from MAEs (at 30 Days)

Preliminary Effectiveness (treatment and technical success)

Secondary study objectives

Technical Success

Treatment Success

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Primary Study ArmExperimental Treatment1 Intervention

The Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Group II: Expanded Use ArmExperimental Treatment1 Intervention

0 / 18Eligibility criteria met