Stent Graft for Aortic Dissection

(PS-IDE Trial)

Overseen By Megan C White, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stent graft, the Valiant PS-IDE Stent Graft, to determine its effectiveness for individuals with type A aortic dissection, a condition where the main artery from the heart tears. The aim is to assess whether the stent graft, inserted into the artery without surgery, can safely repair the tear. This study suits those diagnosed with type A aortic dissection and considered high-risk for surgery. Participants will receive the stent graft and have their progress monitored to ensure the treatment's effectiveness and safety. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for high-risk patients.

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 aortic dissection?

Research has shown that the Valiant PS-IDE Stent Graft demonstrates promising safety results. Earlier studies provided safety data for up to 30 days and 12 months after its use in treating conditions in the chest's main artery. In one study, a few patients experienced serious issues, including death, within 30 days, but these cases were rare compared to the total number of participants. Another study reported excellent results over five years, indicating that the stent graft effectively treated chest injuries.

These findings suggest that the stent graft is generally well-tolerated. However, like any medical treatment, risks exist, so discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Valiant PS-IDE Stent Graft is unique because it offers a minimally invasive option for treating type A aortic dissection, which traditionally requires open-heart surgery. Unlike standard treatments, which involve complex and high-risk surgical procedures, this stent graft is delivered endovascularly, meaning it's inserted through a small incision and guided to the site of the dissection. Researchers are excited about this treatment because it could significantly reduce recovery times and complications associated with open surgery, making it a potentially safer and more efficient alternative for high-risk patients.

What evidence suggests that the Valiant PS-IDE Stent Graft is effective for aortic dissection?

Research has shown that the Valiant Thoracic Stent Graft with the Captivia Delivery System effectively treats tears in the thoracic aorta. Studies have found that this stent graft aids the aorta in healing and returning to a more normal shape over time. It has demonstrated high success rates and favorable outcomes in both short-term and long-term use. While primarily used for type B tears, this trial will assess its application for type A tears. Overall, evidence supports its potential effectiveness in managing complex aortic conditions. ^{1 2 5 6 7}

Who Is on the Research Team?

William Brinkman, MD

Principal Investigator

Cardiac Surgery Specialists

Are You a Good Fit for This Trial?

This trial is for adults with a type A thoracic aortic dissection who need an alternative to traditional surgery. They must have specific measurements of their aorta, be high-risk surgical candidates (ASA score IV), and not pregnant or expected to live less than one year due to another condition.

Inclusion Criteria

My aorta's width is between 28 mm and 44 mm at specific points.

The areas for my graft placement are at least 1 cm apart.

I have a type A thoracic aortic dissection suitable for endovascular repair.

Exclusion Criteria

I am expected to live more than a year, not counting my aortic condition.

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

Patients or their legally authorized representative (LAR) who do not sign the informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular repair of ascending aortic pathologies using the Valiant PS-IDE Stent Graft System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Valiant PS-IDE Stent Graft

Trial Overview The study tests the Valiant PS-IDE Stent Graft System in patients with ascending thoracic aortic pathologies. It aims to see if this endovascular repair method is feasible and safe for those who are unsuitable for conventional surgery.

How Is the Trial Designed?

Group I: Type A Dissection Experimental Treatment 1 Intervention

High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair

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?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

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

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22545887/

procedural and 30-day results of the Valiant Captivia registry In this analysis of procedural and 30-day results, the high technical success and clinical outcome rates showed that the Valiant Thoracic Stent Graft with ...

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

Stent Graft for Aortic Dissection (PS-IDE Trial) The Valiant Thoracic Stent Graft, used in similar procedures for thoracic aortic aneurysms, has shown positive outcomes in both short-term (30-day) and longer- ...

3. 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.

4. 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 ...

5. 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.

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

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

7. 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.