Endovascular Repair for Aortic Disease

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

Trial Summary

What is the purpose of this trial?

This is an early feasibility study that investigates the outcome of selected patients with complex thoracoabdominal aortic lesions who are suitable for endovascular (within the vessel) repair with a physician-modified Medtronic Thoracic Valiant stent graft. The Medtronic Valiant System includes a Valiant Thoracic Stent Graft, a self-expanding, tubular end prosthesis which is modified/customized by the Investigators to fit the patient's anatomy. The device is constructed by making a taper in the larger proximal thoracic device and attaching it to a smaller distal thoracic device. The Viabahn branches for the visceral vessels are sutured to holes made in the tapered section. The modified Valiant stent graft is advanced to the lesion site endoluminally via the iliac/femoral artery. Access for delivery of extensions to the device will be delivered through the left subclavian artery. Upon deployment, the stent graft self-expands at the target location, where it is designed to exclude the lesion by restoring blood flow through the stent graft lumen.

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 data supports the effectiveness of the treatment Physician Modified Endovascular Prosthesis, Modified Medtronic Thoracic Valiant Stent Graft for aortic disease?

Research shows that the Medtronic Valiant Thoracic Stent Graft System has been effective in treating thoracic aortic aneurysms, with studies reporting successful outcomes in both short-term and midterm follow-ups. The Valiant stent graft is designed to be flexible and durable, making it suitable for complex aortic conditions. ^{1 2 3 4 5}

Is the endovascular repair for aortic disease generally safe for humans?

The Valiant Navion and Valiant Thoracic Stent Graft Systems have been studied for safety in treating thoracic aortic aneurysms, showing positive short-term safety results. The Valiant system achieved a high initial technical success rate and was easy to position and deploy, but long-term safety data is still needed. ^{1 2 3 6 7}

How is the Physician Modified Endovascular Prosthesis treatment different from other treatments for aortic disease?

The Physician Modified Endovascular Prosthesis is unique because it involves customizing a standard stent graft to better fit the patient's specific aortic anatomy, which can improve outcomes for complex aortic arch lesions. This approach allows for more precise treatment compared to traditional, off-the-shelf stent grafts. ^{1 2 3 5 8}

Research Team

Rodney A White, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

The Valiant thoracic endograft. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pivotal results for the Medtronic Valiant Thoracic Stent Graft System in the VALOR II trial. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Midterm results from the TRAVIATA registry: treatment of thoracic aortic disease with the valiant stent graft. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Physician-Modified Thoracic Stent-Grafts for the Treatment of Aortic Arch Lesions. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Endovascular exclusion of descending thoracic aortic aneurysms and chronic dissections: Initial clinical results with the AneuRx device. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Results with the Talent thoracic stent graft in the VALOR trial. [2012]

8. England pubmed.ncbi.nlm.nih.gov

Clinical safety and efficacy of a next-generation stent-graft device for thoracic endovascular aortic repair. [2012]