Endovascular Repair for Thoracoabdominal Aortic Aneurysm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Eagleton

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Ruptured aneurysm, Dissection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stent graft system, the Valiant Thoracoabdominal Stent Graft System, designed to repair thoracoabdominal aortic aneurysms—dangerous bulges in the main artery running through the chest and abdomen. The trial evaluates the safety and effectiveness of this device for specific aneurysm types. Participants fall into two groups: one for standard cases and another for more complex cases. The trial seeks participants with large, growing, or painful aneurysms at risk of rupture. As an unphased trial, it offers the chance to contribute to significant research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

What prior data suggests that these devices are safe for endovascular repair of thoracoabdominal aortic aneurysms?

Research has shown that the Valiant Thoracoabdominal Stent Graft System could effectively treat thoracoabdominal aortic aneurysms, which are bulges in the aorta wall, the large blood vessel branching off the heart. A study on a similar stent graft system found a 94% success rate for the procedures. The same study reported a low early death rate of 9%, suggesting the procedure is relatively safe in the short term.

Another study on a related Valiant stent system found it was well-tolerated by patients, leading to special recognition from the FDA for its potential benefits and safety compared to current treatments.

Overall, the treatment appears generally safe and well-tolerated, but individual experiences may vary. Always consult healthcare professionals to make informed decisions about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Valiant Thoracoabdominal Stent Graft System is unique because it offers a new way to manage thoracoabdominal aortic aneurysms by using the Thoracic Bifurcate and Visceral Manifold devices. These devices facilitate endovascular stenting, which is less invasive than traditional open surgery. The system helps maintain blood flow to critical visceral vessels, such as the renal arteries and celiac artery, while ensuring support for the aneurysm. Researchers are excited because this approach could expand treatment options to patients who might not be candidates for conventional surgery, potentially improving outcomes and recovery times.

What evidence suggests that the Valiant Thoracoabdominal Stent Graft System is effective for thoracoabdominal aortic aneurysms?

Research has shown that the Valiant Thoracoabdominal Stent Graft System may effectively treat thoracoabdominal aortic aneurysms, which are bulges in the large artery that carries blood from the heart. This trial includes two arms: the Primary Study Arm and the Expanded Use Arm, both using the Valiant Thoracoabdominal Stent Graft System. Studies have found that this system has low rates of complications, such as the need for additional procedures and deaths related to the aneurysm. Early results indicate a high success rate of 94% in stent placement and a low death rate of 9%. This suggests the stent graft effectively maintains blood flow while repairing the aneurysm, offering hope for patients with this condition. While traditional open surgery remains common, this method, which operates inside the blood vessel, could provide a less invasive option. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have an aneurysm larger than 5.5 cm or twice the size of the normal artery near it.

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

I qualify for the study but have a small vessel diameter of less than 5mm.

Exclusion Criteria

I have a contained rupture.

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

The blood vessels in the area where the treatment will be done are too small.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular stenting using the Valiant Thoracoabdominal Stent Graft System

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including freedom from major adverse events and treatment success

5 years

Regular follow-up visits at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• Valiant Thoracoabdominal Stent Graft System

Trial Overview 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.

How Is the Trial Designed?

Group I: Primary Study Arm Experimental Treatment 1 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 Arm Experimental Treatment 1 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. The expanded use arm provides broaden inclusion criteria to include select patients excluded from the primary study arm.

Who Is Running the Clinical Trial?

Matthew Eagleton

Lead Sponsor

Trials

2

Recruited

190+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Sanford Health

Collaborator

Trials

53

Recruited

2,067,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0741521417302355

Results of the VALOR II trial of the Medtronic Valiant ... The VALOR II 5-year results demonstrate that the reintervention and aneurysm-related death rates are low. The Valiant Thoracic Stent Graft is an effective ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8640886/

Endovascular repair for thoracoabdominal aortic aneurysms Open surgical repair has been the gold standard for treatment of thoracoabdominal aortic aneurysms (TAAA). Currently, open surgical repair has been reserved ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03111459

Repair of Thoracoabdominal Aortic Aneurysms The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2021.05.056

Thoracoabdominal Aortic Disease and Repair ... Valiant thoracoabdominal aortic aneurysm stent graft system (D). ... Outcomes of 3309 thoracoabdominal aortic aneurysm repairs. J Thorac ...

5. cxsymposium.com cxsymposium.com/low-early-mortality-and-high-technical-success-for-novel-thoracic-stent-graft/

Low early mortality and high technical success for novel ... The early results showed high technical success (94%) and low mortality (9%). The Valiant thoracoabdominal aortic aneurysm stent graft is ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666250725001725

Outcomes of fenestrated-branched endovascular aortic ... We reviewed clinical data, imaging, and outcomes of consecutive patients treated by FB-EVAR for complex abdominal and thoracoabdominal aneurysms from April 2007 ...

7. dicardiology.com dicardiology.com/content/fda-grants-breakthrough-device-designation-valiant-thoracoabdominal-aortic-aneurysm-stent

FDA Grants Breakthrough Device Designation for Valiant ... The Valiant Navion LSA branch thoracic stent graft system received breakthrough designation from the FDA in May 2019 to allow for more timely ...