Stent Graft System for Thoracoabdominal Aortic Aneurysm

Recruiting at 2 trial locations

Overseen By Thanh Tran, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

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)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

What data supports the effectiveness of the Stent Graft System for treating thoracoabdominal aortic aneurysm?

Research shows that using fenestrated and branched stent-grafts for thoracoabdominal aortic aneurysms is effective and safe, with studies reporting successful outcomes over a ten-year period and in high-risk patients. ^{1 2 3 4 5}

Is the Stent Graft System for Thoracoabdominal Aortic Aneurysm safe for humans?

Research shows that the stent graft system, including various techniques and designs, has been studied for safety in treating thoracoabdominal aortic aneurysms. These studies generally support its safety, especially for patients who are at high risk for traditional surgery. ^{1 2 5 6 7}

How is the TAAA Debranching Stent Graft System treatment different from other treatments for thoracoabdominal aortic aneurysm?

The TAAA Debranching Stent Graft System is unique because it is designed to preserve blood flow to the side branches of the aorta, which is crucial for maintaining circulation to vital organs. This system uses a specialized stent (a small mesh tube) that can be customized to fit the patient's anatomy, offering a more tailored approach compared to standard treatments. ^{2 3 4 8 9}

What is the purpose of this trial?

The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study. The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.

Research Team

Murray Shames, MD

Principal Investigator

University of South Florida

Eligibility Criteria

This trial is for adults over 18 with thoracic aortic aneurysms at risk of rupture, symptomatic aneurysms larger than 4.5 cm, or certain types of dissections. Candidates must have specific anatomical features that fit the device's requirements and cannot be good candidates for open surgery or other available endovascular prostheses.

Inclusion Criteria

I have major issues with two of my body's systems like heart or lungs.

My iliac artery or aorta has a secure attachment site that's at least 15 mm long and 8-25 mm wide.

You are expected to live for more than 1 year.

Exclusion Criteria

Unwilling to comply with the follow-up schedule

I am allergic to blood thinners or contrast dyes and it can't be managed.

I have a connective tissue disorder like Marfan or Ehler's Danlos Syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the TAAA Debranching Stent Graft System

30 days

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

2 additional years

Treatment Details

Interventions

• TAAA Debranching Stent Graft System

Trial Overview The study tests a TAAA Debranching Stent Graft System designed to treat complex aortic aneurysms. It aims to collect preliminary safety data and assess device functionality in a small group of patients to minimize risk while gathering valuable information.

Participant Groups

Group I: Primary study Experimental Treatment 1 Intervention

Patients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System.

Group II: Expanded selection Experimental Treatment 1 Intervention

Patients who fail to meet inclusion criteria for the primary study arm may be enrolled under the expanded selection arm and be treated with the TAAA Debranching Stent Graft System.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Sanford Health

Collaborator

Trials

53

Recruited

2,067,000+

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

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Fenestrated and Branched Stent-Grafts for the Treatment of Thoracoabdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis. [2022]

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

An endovascular system for thoracoabdominal aortic aneurysm repair. [2017]

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

Endovascular Repair of a Thoracoabdominal Aortic Aneurysm With a Patient-Specific Fenestrated-Branched Stent-Graft. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Editor's Choice - Ten-year Experience with Endovascular Repair of Thoracoabdominal Aortic Aneurysms: Results from 166 Consecutive Patients. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of High Surgical Risk Thoracoabdominal Aortic Aneurysms with Stent Graft and Multilayer Bare Stents Joint Technique: Mid-Long-Term Clinical Results. [2020]

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

Staged total abdominal debranching and thoracic endovascular aortic repair for thoracoabdominal aneurysm. [2021]

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

Early experience with the first commercially available off-the-shelf multibranched endograft (t-branch) in the treatment of thoracoabdominal aortic aneurysms. [2022]

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

A standardized multi-branched thoracoabdominal stent-graft for endovascular aneurysm repair. [2021]

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

A new technique of branched stent graft treatment for ruptured thoracoabdominal aortic aneurysms. [2016]