Stent Graft System for Thoracoabdominal Aortic Aneurysm

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stent graft system designed to treat thoracoabdominal aortic aneurysms, dangerous bulges in the major artery that can lead to severe health issues if they rupture. The goal is to determine if this new device, the TAAA Debranching Stent Graft System, is safe and effective compared to other treatments. It may suit individuals with rapidly growing or unusually large aneurysms that cause symptoms affecting daily life. The study will collect early data on the device's effectiveness and safety. As an unphased trial, it offers patients the chance to contribute to early research on a potentially life-saving treatment.

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 prior data suggests that this stent graft system is safe for treating thoracoabdominal aortic aneurysm?

Research has shown that the TAAA Debranching Stent Graft System offers promising safety results. In a previous study, the device successfully treated 99% of targeted blood vessels and maintained 96% of them open and functioning after one year. This indicates that the system is generally well-tolerated by patients.

Other studies have compared this method to traditional open surgery for thoracoabdominal aortic aneurysms, which are bulges in the main artery from the heart. These studies found that the stent graft system may lead to fewer complications and is less invasive, aiding in better patient recovery.

In summary, while any medical procedure carries some risks, the TAAA Debranching Stent Graft System has demonstrated good safety results in clinical settings. This makes it a potentially safer option compared to more invasive surgeries for treating aortic aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TAAA Debranching Stent Graft System because it offers a novel approach to treating thoracoabdominal aortic aneurysms. Unlike traditional surgery, which can be invasive and risky, this system uses a minimally invasive stent graft technique to reroute blood flow around the aneurysm. This method aims to reduce recovery time and the potential for complications. Moreover, it provides an option for patients who may not qualify for conventional treatments, expanding access to care for those with complex medical needs.

What evidence suggests that this stent graft system is effective for thoracoabdominal aortic aneurysm?

Research has shown that the TAAA Debranching Stent Graft System, which trial participants will receive, delivered promising results in earlier studies. It successfully treated 99% of targeted blood vessels and kept 96% open after one year. This device aims to reduce complications compared to traditional open surgery, which often carries significant risks. Although hybrid repairs have raised concerns, such as a 14% chance of spinal cord injury in other studies, this new graft system offers potential benefits. Early findings suggest it could be used for various aneurysm cases and improve long-term blood vessel function. ^{1 3 4 6 7}

Who Is on the Research Team?

Murray Shames, MD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

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.

You are expected to live for more than 1 year.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8691180/

Total abdominal debranching hybrid thoracoabdominal aortic ... The hybrid TAAA repair avoids thoracotomy but requires laparotomy and carries high morbidity and mortality (eg, operative mortality, 4%-26% and renal failure, 4 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3741770/

Clinical outcomes of hybrid repair for thoracoabdominal ... At median follow-up of 23.9 months procedure-related mortality rate was 9.6%: two patients died from visceral graft occlusion and three from aortic rupture.

3. sciencedirect.com sciencedirect.com/science/article/pii/S277268782400103X

Hybrid Repair of a Thoracoabdominal Aortic Aneurysm as ... The North American Complex Abdominal Aortic Debranching Registry reported a 14 % incidence of spinal cord injuries in 200 patients undergoing hybrid repair.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03075748

Visceral Manifold Study for the Repair of TAAA | ... This study is a prospective, single-center, non-randomized, single-arm study to evaluate the therapeutic benefit of the TAAA Debranching Stent Graft System. A ...

5. annalscts.com annalscts.com/article/view/565/1319

Thoracoabdominal aortic aneurysm: hybrid repair outcomes Kaplan-Meier overall survival was 78% at 1 year and 62% at 5 years, with a 5-year aorta-specific survival of 87%. Conclusions: These updated results continue to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512131/

Hybrid Thoracoabdominal Aortic Aneurysm Repair After Prior ... The present study aims to address this gap by comparing the short-term and long-term outcomes of hybrid TAAA repair in 2 distinct patient ...

7. annalscts.com annalscts.com/article/view/514/html

Clinical outcomes of hybrid repair for thoracoabdominal ... Thoracoabdominal aortic aneurysm (TAAA) hybrid repair consists of aortic visceral branch rerouting followed by TAAA endograft exclusion.