Endovascular Repair for Aortic Disease

No longer recruiting at 1 trial location

Overseen By Ankur Gupta, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rodney A. White, MD

Disqualifiers: Pregnancy, Pediatric, Infection, Allergies, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to repair complex thoracoabdominal aortic lesions using a modified stent graft, known as the Physician Modified Endovascular Prosthesis. The stent graft, a tube-like device, helps redirect blood flow and is placed through a small incision in a blood vessel. The trial aims to determine if this approach can safely and effectively treat the condition. It seeks participants who require endovascular repair for their aortic condition and have specific blood vessel characteristics. Individuals who often face surgical risks might be well-suited for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for complex aortic conditions.

Will I have to stop taking my current medications?

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.

What prior data suggests that this endovascular device is safe for aortic repair?

Research has shown that the Medtronic Valiant Thoracic Stent Graft, used in this trial, is safe and effective for treating certain aortic problems. One study used this stent graft for patients with bulges in the descending part of the aorta, and it proved safe and effective over a year. Another study examined a version of the stent graft that doctors modified for more complex aortic issues. This modified version was found to be a workable and potentially effective solution for certain thoracic aortic conditions. Although these studies provide promising evidence, the modified stent graft remains experimental. While some safety information exists, more research is needed to fully understand its long-term safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Physician Modified Endovascular Prosthesis is unique because it offers a customized approach to repairing aortic diseases, specifically targeting thoracoabdominal lesions. Unlike traditional surgical repair methods that are more invasive, this treatment involves endoluminal exclusion, which means it works from inside the blood vessel to seal off the affected area. Researchers are excited about this treatment due to its potential to reduce recovery times and lower the risk of complications compared to open surgery. By modifying the prosthesis to suit individual patient anatomy, it promises to enhance precision and effectiveness in treating complex aortic conditions.

What evidence suggests that this endovascular device is effective for aortic disease?

Research has shown that the Medtronic Valiant Thoracic Stent Graft, modified for this trial as the Physician Modified Endovascular Prosthesis, safely and effectively treats aortic conditions. Studies have found that similar doctor-modified stent grafts can successfully address complex aortic problems. The device expands to fit the blood vessel, creating a new path for blood flow and bypassing the damaged area. This method has successfully treated various issues in the thoracic aorta. Although this technique appears promising, testing its success in more complex cases, like those in this trial, remains important. ^{2 3 6 7 8}

Who Is on the Research Team?

Rodney A White, MD

Principal Investigator

Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA

Are You a Good Fit for This Trial?

This trial is for adults over 21 with complex Type IV thoracoabdominal aortic lesions who are high-risk surgical candidates. They must have specific anatomical features that fit the criteria for endovascular repair, such as compatible ileofemoral access and left subclavian artery anatomy. Pregnant individuals, those likely to infect the stent graft, or with allergies to its materials cannot participate.

Inclusion Criteria

My aorta near my heart fits the required size and shape for a safe procedure.

I have a complex aortic lesion and am eligible for a non-surgical repair procedure.

You need to have a specific type of access in your body that can work with a certain medical device.

Exclusion Criteria

I have a condition that could infect my heart valve or stent.

Patients who fail to sign informed consent

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endoluminal exclusion of thoracoabdominal lesion using a physician-modified Medtronic Thoracic Valiant stent graft

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness at discharge and 1 month post-implantation

1 month

2 visits (in-person)

Extended Follow-up

Participants are monitored for safety and effectiveness at 6 and 12 months post-implantation

12 months

2 visits (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness up to 5 years post-implantation

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Physician Modified Endovascular Prosthesis

Trial Overview The study tests a modified Medtronic Valiant Thoracic Stent Graft on patients with aortic disease. The device is customized by doctors to match patient anatomy and delivered through arteries to exclude the lesion and restore blood flow.

How Is the Trial Designed?

Group I: Endovascular Device Implantation Experimental Treatment 2 Interventions

Endoluminal exclusion of thoracoabdominal lesion

Physician Modified Endovascular Prosthesis is already approved in United States, European Union for the following indications:

Approved in United States as Valiant Thoracic Stent Graft for:

• Endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta

Approved in European Union as Valiant Navion Thoracic Stent Graft System for:

• Thoracic aortic aneurysms (TAA), type B aortic dissection (TBAD), intramural hematoma (IMH), penetrating atherosclerotic ulcer (PAU), and blunt thoracic aortic injury (BTAI)

Who Is Running the Clinical Trial?

Rodney A. White, MD

Lead Sponsor

Rodney A. White, M.D.

Lead Sponsor

Trials

4

Recruited

390+

Long Beach Memorial Medical Center

Collaborator

Trials

7

Recruited

4,100+

Published Research Related to This Trial

The Medtronic Valiant® stent graft, a second-generation device, has been developed with technical improvements over the earlier Medtronic Talent® stent graft, enhancing its effectiveness in treating aortic diseases.

Thoracic endovascular aortic repair using these stent grafts effectively excludes dangerous aortic conditions like aneurysms and dissections from circulation, reducing the risk of complications such as rupture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety and efficacy of a next-generation stent-graft device for thoracic endovascular aortic repair. Eggebrecht, H., Schmermund, A., Voigtländer, T.[2012]

The study of 92 patients undergoing thoracic endovascular aortic repair (TEVAR) with the Valiant Thoracic Stent Graft showed a high technical success rate of 86.9% and low all-cause mortality of 3.3% within 30 days, indicating the procedure is generally safe.

At 1 year, cumulative survival was 95.5%, and 58.4% of patients experienced a significant reduction in aortic diameter, demonstrating the efficacy of TEVAR in treating aortic conditions, although some complications related to deployment were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm results from the TRAVIATA registry: treatment of thoracic aortic disease with the valiant stent graft. Torsello, GB., Torsello, GF., Osada, N., et al.[2010]

In a study involving 87 patients treated with the Valiant Navion stent graft system for descending thoracic aortic aneurysms, there were no access or deployment failures, and only 2.3% experienced a major device effect within 30 days, indicating high safety and efficacy.

The occurrence of endoleaks was low at 2.5%, and the overall freedom from all-cause mortality was 97.7%, suggesting that the Valiant Navion stent graft system is a promising option for patients with complex aortic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. Azizzadeh, A., Desai, N., Arko, FR., et al.[2020]

The Medtronic Valiant endoprosthesis, designed for treating thoracic aortic pathologies, demonstrated a high initial technical success rate of 93% in a study involving 28 patients, indicating its efficacy and ease of deployment.

Endovascular techniques, like the Valiant system, aim to reduce the risks associated with traditional open surgery for thoracic aortic replacement, such as mortality and morbidity from extensive surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Valiant thoracic endograft. Brooks, M., Loftus, I., Morgan, R., et al.[2022]

The study involved 26 patients with descending thoracic aortic aneurysms treated with a new self-expanding endovascular prosthesis, achieving a high technical success rate of 96% with no surgical conversions.

Follow-up results over an average of 9 months showed effective exclusion of the aneurysms in most patients, with no endoleaks and either stable or decreasing aneurysm volumes, indicating the potential efficacy of this treatment for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular exclusion of descending thoracic aortic aneurysms and chronic dissections: Initial clinical results with the AneuRx device. White, RA., Donayre, CE., Walot, I., et al.[2022]

The Valiant Thoracic Stent Graft System demonstrated a high success rate in deployment (96.3%) and low rates of serious complications, with a 30-day perioperative mortality of only 3.1% and no cases of paraplegia or major strokes reported.

At 12 months, the Valiant stent graft showed noninferior all-cause mortality compared to the previous Talent stent graft and achieved a high effectiveness rate of 97.4% in preventing aneurysm growth and the need for secondary procedures, indicating it is a safe and effective option for treating descending thoracic aortic aneurysms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal results for the Medtronic Valiant Thoracic Stent Graft System in the VALOR II trial. Fairman, RM., Tuchek, JM., Lee, WA., et al.[2013]

In a study of 36 high-risk patients with aortic arch lesions, physician-modified thoracic stent-grafts demonstrated technical success in all cases, with no type I endoleaks and a mean modification time of just 18 minutes.

The short-term outcomes were promising, with a 30-day mortality rate of 6% and no conversions to open repair during an average follow-up of 11.4 months, although overall mortality was 14% and aorta-related mortality was 6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-Modified Thoracic Stent-Grafts for the Treatment of Aortic Arch Lesions. Canaud, L., Baba, T., Gandet, T., et al.[2019]

In a 5-year follow-up of 195 patients undergoing thoracic endovascular aneurysm repair (TEVAR) with the Medtronic Talent Stent Graft, there was a high freedom from aneurysm-related mortality (96.1%) and aneurysm rupture (97.1%), indicating the procedure's long-term efficacy.

The study also reported a low incidence of serious complications, such as stent graft migration (≤ 1.8%) and type I endoleaks (up to 6.3%), suggesting that TEVAR is a safe option for patients at low or moderate risk for open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results with the Talent thoracic stent graft in the VALOR trial. Foley, PJ., Criado, FJ., Farber, MA., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8759509/

Outcomes of single physician-modified fenestrated stent ... The single fenestrated stent graft technique is feasible and effective for endovascular repair of thoracic aortic pathologies involving the distal aortic arch.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02524834

Endovascular Repair of Descending ThoracoAbdominal ... The Medtronic Valiant System includes a Valiant Thoracic Stent Graft, a self-expanding, tubular end prosthesis which is modified/customized by the Investigators ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1078588421000691

Comprehensive Review of Physician Modified Aortic Stent ... Physician modified stent grafts (PMSGs) present satisfactory results in selected cases of complex aortic pathologies. However, the technique lacks ...

4. jvascsurg.org jvascsurg.org/article/S0741-5214(12)01110-X/fulltext

Pivotal results for the Medtronic Valiant Thoracic Stent Graft ... The VALOR II 12-month results demonstrate that the Medtronic Valiant thoracic stent graft is a safe and effective treatment for patients with ...

5. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/aortic-stent-grafts/valiant-thoracic-stent-graft-with-captivia-delivery-system/clinical-outcomes.html

Clinical Outcomes - Valiant Thoracic Stent Graft with the ... Proven clinical track record — five-year outcomes in all descending thoracic aortic pathologies. Review the results with Valiant™ Captivia™ clinical trials:.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100040S036B.pdf

summary of safety and effectiveness data (ssed) The study was limited to the use of the device for the treatment of descending thoracic aortic aneurysms (DTAA) and penetrating aortic ulcers ( ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S074152141201110X

Pivotal results for the Medtronic Valiant Thoracic Stent Graft ... The VALOR II 12-month results demonstrate that the Medtronic Valiant thoracic stent graft is a safe and effective treatment for patients with descending ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11001489/

Mid-term outcomes of physician-modified endograft ... Our goal was to evaluate early and mid-term outcomes of physician-modified endografting for pararenal and thoraco-abdominal aortic aneurysms from 10 Japanese ...