Endovascular Stent Graft for Aortic Dissection

Recruiting at 1 trial location

Overseen By Rodney A White, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rodney A. White, MD

Disqualifiers: Pregnancy, Pediatric, Infection risk, 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: 2

Duration: 1 day (procedure)

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stent graft for repairing issues in the ascending thoracic aorta, the main blood vessel leading away from the heart. It evaluates the effectiveness of this device for conditions such as aortic dissection, intramural hematoma, and pseudoaneurysm, which can be life-threatening if untreated. The trial uses the Medtronic Valiant PS-IDE Stent Graft, which has already succeeded in treating similar issues in another part of the aorta. Suitable participants include those with conditions like Type A aortic dissection who are high-risk for open surgery. As an unphased trial, this study offers patients the chance to contribute to medical advancements and potentially benefit from innovative treatment options.

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 the Valiant PS-IDE Stent Graft is safe for endovascular repair of the ascending aorta?

Research has shown that the Valiant PS-IDE Stent Graft is safe for use in the descending thoracic aorta. Designed to treat serious aortic issues, this device has undergone thorough testing with positive outcomes. Studies have found it to be well-tolerated and effective for at least five years, with patients experiencing very few side effects. Although this study focuses on the ascending thoracic aorta, the stent graft's safe use in similar situations suggests it should perform well here too. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Valiant PS-IDE Stent Graft for aortic dissection is unique because it offers a minimally invasive option compared to the traditional open surgical repair. Typically, treating aortic dissection involves major surgery, which can be risky and involves a longer recovery period. This stent graft is delivered endovascularly, meaning it's inserted through a small incision and navigated through the blood vessels to the affected area. Researchers are excited because this less invasive approach could mean shorter hospital stays and faster recovery times for patients, making it a potentially safer and more efficient alternative.

What evidence suggests that the Valiant PS-IDE Stent Graft is effective for treating ascending thoracic aorta pathologies?

Research has shown that the Valiant Stent Graft effectively treats type B aortic dissections, which are tears in the aorta's wall, the main artery carrying blood from the heart. It redirects blood flow and aids in aortic healing. Studies have found that it promotes positive changes in the aorta and remains safe for up to five years post-treatment. Made from strong materials, the stent graft covers the tears and stabilizes the aorta. In this trial, the Valiant PS-IDE Stent Graft will be used for endovascular repair of the ascending aorta, and it is expected to perform well for type A cases due to the similarities between type A and type B dissections. The Valiant Captivia system has been used worldwide, supporting its reliability and effectiveness in managing serious aortic conditions. ^{1 3 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Valiant PS-IDE 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.

How Is the Trial Designed?

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

Endovascular repair with Valiant PS-IDE Stent Graft

Valiant PS-IDE Stent Graft is already approved in European Union, United States for the following indications:

Approved in European Union as Valiant Captivia Stent Graft for:

• Thoracic aortic aneurysms (TAA)
• Type B aortic dissection (TBAD)
• Intramural hematoma (IMH)
• Penetrating atherosclerotic (PAU)
• Blunt thoracic aortic injury (BTAI)

Approved in United States as Valiant Captivia Stent Graft for:

• Thoracic aortic aneurysms (TAA)
• Type B aortic dissection (TBAD)
• Intramural hematoma (IMH)
• Penetrating atherosclerotic (PAU)
• 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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. 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 ... The Valiant™ Captivia™ system effectively treated acute complicated type B aortic dissections with positive aortic remodeling through five years. Graph ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31991136/

Five-Year Outcomes From the United States Pivotal Trial of ... This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01114724

NCT01114724 | Study to Evaluate the ... The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100040b.pdf

Summary of Safety and Effectiveness Data - accessdata.fda.gov Testing verified that the Valiant Thoracic Stent Graft with the Captivia. Delivery System met its product performance and design specifications.

5. withpower.com withpower.com/trial/phase-11-2018-f498e

Stent Graft for Aortic Dissection (PS-IDE Trial) The Valiant Stent Graft has been evaluated in several studies, showing safety data for up to 30 days and 12 months after use in treating thoracic aortic ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/p100040s008b.pdf

Summary of Safety and Effectiveness Data (SSED) The Valiant Thoracic Stent Graft is intended to be delivered endoluminally via access through the femoral or iliac artery to the site ofthe ...

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

summary of safety and effectiveness data (ssed) The results from this study, with consideration of the clinical data from the evaluation of the Valiant Captivia Thoracic Stent Graft System, in ...

8. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiovascular/aortic/aortic-stent-grafts/valiant-thoracic-stent-graft-with-captivia-delivery-system.html

Valiant™ Captivia™ thoracic stent graft system The Valiant™ Captivia™ thoracic stent graft system is designed to treat all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), ...