Stent Graft for Aortic Aneurysm

Overseen By Geoffrey Answini, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Christ Hospital

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Ruptured aneurysm, Dissection, 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: Immediate procedure

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Medtronic Valiant Thoracoabdominal Stent Graft System, for treating thoracoabdominal aortic aneurysms. These aneurysms are bulges in a major blood vessel that can cause serious problems if they burst. The trial aims to determine the device's safety and effectiveness in repairing these aneurysms. Suitable candidates for this trial have a large or growing aneurysm and specific blood vessel characteristics that permit the device's use. As an unphased trial, it offers patients the chance to contribute to pioneering research that could lead to innovative treatment options.

Do I need to stop my current medications for the trial?

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 stent graft is safe for repairing thoracoabdominal aortic aneurysms?

Research has shown that the Medtronic Valiant Thoracoabdominal Stent Graft System has treated similar conditions before. This device updates a previously approved stent graft system. These grafts assist in treating the aorta, the large artery that carries blood from the heart to the rest of the body.

Previous patients have generally tolerated the system well. While some reports of side effects exist, this is not unusual for treatments involving major arteries. Several studies have tested the device's safety in humans.

The FDA has approved this stent graft system for other conditions, indicating a certain level of safety. However, this trial aims to better understand its safety in treating thoracoabdominal aortic aneurysms, which are bulges in weakened artery walls. Since this trial is not in its early stages, the device has already demonstrated some safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Medtronic Valiant Thoracoabdominal Stent Graft System is unique because it offers a minimally invasive approach to treating aortic aneurysms, which are typically addressed with open surgical repair or other endovascular grafts. This stent graft is specifically designed to accommodate the complex anatomy of the thoracoabdominal region, providing a more tailored fit and potentially reducing complications. Researchers are excited because this system may improve patient outcomes by decreasing recovery time and minimizing the risk of surgery-related complications, making it a promising alternative to current treatment options.

What evidence suggests that the Medtronic Valiant Thoracoabdominal Stent Graft System is effective for repairing thoracoabdominal aortic aneurysms?

Studies have shown that the Medtronic Valiant Thoracic Stent Graft System effectively treats thoracic aortic aneurysms (TAAs). This device strengthens the aorta, a large blood vessel, to prevent it from bursting. Patients using similar devices have experienced positive outcomes, with the stent graft maintaining proper blood flow and reducing the risk of complications. The Valiant system is designed to fit various aortic shapes, making it suitable for many patients. In this trial, participants will receive treatment with the Medtronic Valiant Thoracoabdominal Stent Graft System, which research suggests could be a promising option for those with thoracoabdominal aortic aneurysms. ^{1 2 3 5 6}

Who Is on the Research Team?

Geoffrey Answini, MD

Principal Investigator

The Christ Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with thoracoabdominal aortic aneurysms larger than 5.5 cm or growing quickly, at risk of rupture, or symptomatic. Candidates must have suitable anatomy for the stent graft and expect to live more than a year but can't be pregnant, breastfeeding, allergic to device materials like nitinol or polyester, have severe infections, kidney issues (creatinine >2.0 mg/dL), unmanageable blood clotting disorders, certain connective tissue diseases, or be unsuitable for X-ray imaging.

Inclusion Criteria

Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm

Exclusion Criteria

My anatomy prevents proper blood flow in my left subclavian artery.

Urgent or emergent presentation

You have allergies to the materials used to make the medical devices, such as nickel-titanium, polyester, platinum-iridium, PTFE, platinum, gold, polyethylene, or stainless steel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the Medtronic Valiant Thoracoabdominal Stent Graft System

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 month, 6 months, 12 months, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Valiant Thoracoabdominal Stent Graft System

Trial Overview The Medtronic Valiant Thoracoabdominal Stent Graft System is being tested in patients with specific types of aortic aneurysms. The study aims to evaluate the safety and initial effectiveness of this device by monitoring technical and treatment success over time after implantation.

How Is the Trial Designed?

Group I: Primary Study Arm Experimental Treatment 1 Intervention

Patients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.

Group II: Expanded Selection Arm Experimental Treatment 1 Intervention

Patients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.

Medtronic Valiant Thoracoabdominal Stent Graft System is already approved in United States, European Union for the following indications:

Approved in United States as Valiant Thoracic Stent Graft with the Captivia Delivery System for:

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

Approved in European Union as Valiant Thoracic Stent Graft with the Captivia Delivery System for:

• Endovascular repair of all lesions of the descending thoracic aorta

Who Is Running the Clinical Trial?

The Christ Hospital

Lead Sponsor

Trials

20

Recruited

1,400+

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

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]

In a study of 50 patients treated with the Valiant Captivia endograft for blunt thoracic aortic injury, 5-year follow-up showed an impressive survival rate of 85.2%, with no occurrences of stroke or spinal cord ischemia.

The stent graft demonstrated excellent long-term performance, maintaining complete exclusion of the injury without any device-related complications such as kinking, fracture, or migration, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Outcomes From the United States Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury. Patel, HJ., Azizzadeh, A., Matsumoto, AH., et al.[2020]

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 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 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]

Citations

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

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100040S036D.pdf

Valiant Navion™ - accessdata.fda.gov Because the Valiant Navion thoracic stent graft system is expected to perform similarly to Valiant Captivia thoracic stent graft system, the clinical study ( ...

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

Valiant Thoracic Stent Graft with the Captivia Delivery System The Valiant™ Captivia™ stent graft system is designed to treat all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), type B ...

4. jvascsurg.org jvascsurg.org/article/S0741-5214(19)30334-9/fulltext

Pivotal results for the Valiant Navion stent graft system in ... The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic ...

5. evtoday.com evtoday.com/articles/2019-jan/the-valiant-navion-thoracic-stent-graft-system-created-to-tackle-challenging-scenarios

The Valiant Navion™ Thoracic Stent Graft System An overview of the enhanced features of this next-generation thoracic stent graft system and an illustrative case report demonstrating its utility in ...

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

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