Stent Graft for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Overseen by Geoffrey Answini, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Christ Hospital

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Ruptured aneurysm, Dissection, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.

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 data supports the effectiveness of the treatment Medtronic Valiant Thoracoabdominal Stent Graft System?

The Valiant Navion stent graft system showed positive 30-day safety and effectiveness results in treating descending thoracic aortic aneurysms, and the Valiant Thoracic Stent Graft System demonstrated promising outcomes in both short-term and five-year follow-ups for various aortic conditions. ^{1 2 3 4 5}

Is the Stent Graft for Aortic Aneurysm generally safe for humans?

The Valiant stent graft systems, including the Navion and Captivia, have been evaluated for safety in several studies. These studies report on short-term safety outcomes, such as 30-day results, indicating that the stent grafts are generally safe for use in humans, although rare complications like misaligned deployment have been noted. ^{1 2 3 5 6}

How is the Medtronic Valiant Thoracoabdominal Stent Graft System treatment different from other treatments for aortic aneurysms?

The Medtronic Valiant Thoracoabdominal Stent Graft System is unique because it is a third-generation, low-profile device specifically designed for thoracic endovascular aortic repair (TEVAR), offering a minimally invasive alternative to open surgery for treating aortic aneurysms. It features advanced delivery systems like the Captivia, which aim to improve precision and safety during deployment. ^{1 2 3 5 6}

Research Team

Geoffrey Answini, MD

Principal Investigator

The Christ Hospital

Eligibility Criteria

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

The patient has a large aneurysm, or a history of aneurysm growth, or an aneurysm that is at risk of rupturing. The patient also must have certain blood vessel conditions and be at least 18 years old with a life expectancy of more than 1 year.

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.

Trial Timeline

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

Treatment Details

Interventions

• Medtronic Valiant Thoracoabdominal Stent Graft System (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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Christ Hospital Cincinnati, OH

Who Is Running the Clinical Trial?

The Christ Hospital

Lead Sponsor

Trials

20

Patients Recruited

1,400+

Medtronic

Industry Sponsor

Trials

627

Patients Recruited

767,000+

Findings from Research

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]

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]

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]

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 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]

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

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

2. 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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Five-Year Outcomes From the United States Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury. [2020]

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

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

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

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