Endovascular Stent Graft for Aortic Dissection

Recruiting at1 trial location

Overseen by Ali Khoynezhad, M.D. PhD.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rodney A. White, M.D.

Disqualifiers: Pregnancy, Pediatric, Infection risk, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 Valiant PS-IDE Stent Graft for aortic dissection?

The Valiant Thoracic Stent Graft System has shown positive results in treating descending thoracic aortic aneurysms, with studies reporting successful outcomes in both short-term and procedural evaluations. This suggests that the Valiant stent grafts, including the Valiant PS-IDE, may be effective for similar conditions like aortic dissection. ^{1 2 3 4 5}

Is the Valiant Stent Graft safe for use in humans?

The Valiant Stent Graft has been used in various studies for treating thoracic aortic aneurysms, and safety data from these studies show that it is generally safe for human use, with some complications like misaligned deployment reported in rare cases. ^{1 2 4 5 6}

How is the Valiant PS-IDE Stent Graft treatment different from other treatments for aortic dissection?

The Valiant PS-IDE Stent Graft is unique because it is a third-generation endovascular device designed to be flexible and low-profile, allowing it to navigate through complex and narrow blood vessels with minimal risk of complications, unlike traditional open surgery which involves significant risks. This stent graft system is specifically engineered to be durable and easy to deploy, making it a novel option for treating aortic dissections. ^{1 2 3 4 5}

Research Team

Rodney A White, M.D.

Principal Investigator

LA BioMedical Research Institute at Harbor-UCLA Medical Center

Ali Khoynezhad, M.D. PhD.

Principal Investigator

LA BioMedical Research Institute at Harbor-UCLA Medical Center

Eligibility Criteria

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.

Inclusion Criteria

My aorta is the right size for the procedure.

I have a specific type of aortic dissection or related condition and am a candidate for a less invasive repair.

The patient must be deemed high-risk surgical candidate according to the following established criteria: ASA (American Society of Anesthesiologists) class IV

Exclusion Criteria

Patients or their legally authorized representatives who do not sign the informed consent

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

Your doctor expects you to live less than one year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular repair with Valiant PS-IDE Stent Graft for ascending aortic pathologies

1 day (procedure)

1 visit (in-person)

Initial Follow-up

CT with and without contrast and echocardiogram 30 days after the Medtronic device is implanted

4 weeks

1 visit (in-person)

Long-term Follow-up

CT with and without contrast at 6 and 12 months post procedure and once a year from 2 years through 5 years after the implant

5 years

Annual visits (in-person)

Treatment Details

Interventions

• Valiant PS-IDE Stent Graft (Stent Graft)

Trial Overview 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.

Participant Groups

Group I: Endovascular repair of ascending aorta Experimental Treatment 1 Intervention

Endovascular repair with Valiant PS-IDE Stent Graft

Who Is Running the Clinical Trial?

Rodney A. White, M.D.

Lead Sponsor

Trials

4

Recruited

390+

Findings from Research

The Valiant NavionTM stent graft system demonstrated a high technical success rate of 94.7% in a study of 21 Asian patients undergoing thoracic endovascular aortic repair, with no major vascular complications reported.

The procedure showed versatility and safety, with a 30-day survival rate of 100% and a mean hospital stay of just 5.3 days, indicating it is an effective option for treating various aortic pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Valiant NAVION stent graft system application: First Asian case-series analysis. Chow, SCY., Ho, JYK., Fujikawa, T., et al.[2021]

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 Valiant Thoracic Stent Graft with the Captivia Delivery System achieved a 100% technical success rate in 100 patients, indicating its reliability for treating thoracic aortic conditions.

The 30-day outcomes showed a 4% all-cause mortality rate, with most complications being procedure-related, suggesting that while the device is effective, careful monitoring is necessary for potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry. Heijmen, RH., Thompson, MM., Fattori, R., et al.[2022]

Two cases of misaligned deployment of the Valiant Captivia stent graft were reported after treating thoracic aneurysms, a complication not previously documented in the literature.

The paper discusses potential factors contributing to this misalignment and describes a bailout technique used to address the issue during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two cases of misaligned deployment of Valiant Captivia thoracic stent graft. Mlynski, A., Marzelle, J., Desgranges, P., et al.[2012]

References

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

Valiant NAVION stent graft system application: First Asian case-series analysis. [2021]

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

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

3. Italy pubmed.ncbi.nlm.nih.gov

The Valiant thoracic endograft. [2022]

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

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

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

Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry. [2022]

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

Two cases of misaligned deployment of Valiant Captivia thoracic stent graft. [2012]