Aortic Endografts for Aortic Aneurysm

Overseen By Rebecca St John

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Infection, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Procedure duration varies

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of three new devices designed to treat complex aortic problems, specifically aortic aneurysms (a bulging in the wall of the aorta) that involve vital areas of the aorta. These devices, including the Cook Custom Aortic Endograft, offer a less invasive option, potentially shortening hospital stays and reducing complications. People with stable aortic issues, such as large or fast-growing aneurysms near the visceral arteries (blood vessels to organs like the stomach and liver), might be good candidates. Participants will undergo various tests, including blood tests and scans, to tailor the treatment to their specific condition. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could potentially improve patient outcomes.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a history of anaphylactic reaction to contrast material, it must be adequately premedicated. Please consult with the trial coordinators for more details.

What prior data suggests that these investigational devices are safe for treating aortic pathologies?

Research has shown that the Zenith t-Branch Endovascular Graft is generally safe. Studies have reported positive short-term and one-year survival and health outcomes, indicating that patients usually tolerate it well.

Less detailed information exists about the Cook Custom Aortic Endograft and Surgeon-Modified Endograft. As these devices remain under testing and the study phase is unspecified, detailed safety data might not yet be available. However, these endografts are based on models already used in medical practice, suggesting a basic level of safety.

Overall, these investigational devices aim to safely treat complex aortic issues with a less invasive method. It is important to consult a healthcare professional before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for aortic aneurysms because they offer personalized, innovative solutions that standard open surgery or traditional endovascular repair might not provide. The Cook Custom Aortic Endograft and the Surgeon-Modified Endograft are both tailored to fit the patient's unique anatomy, potentially offering better seal and fixation by including up to five fenestrations and branches. Meanwhile, the Zenith t-Branch Endovascular Graft features four branches and unique barbs for secure placement, facilitating connections with major arteries like the celiac and renal arteries. These features aim to improve outcomes by precisely addressing the complex structures of aortic aneurysms, which can lead to less invasive and more effective treatments.

What evidence suggests that these investigational devices are effective for treating aortic pathologies?

Research has shown that certain medical devices, such as the Cook Custom Aortic Endograft and the Zenith t-Branch Endovascular Graft, effectively treat complex aortic aneurysms. In this trial, participants will receive either the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, or the Surgeon-Modified Endograft. Studies have found that the Zenith t-Branch device is safe, with low death and complication rates both 30 days and one year after the procedure. The Cook Custom Aortic Endograft also demonstrates excellent long-term results in similar cases. These devices are custom-made to fit each patient's aorta, which helps them stay in place better and may lead to fewer problems. Overall, early evidence suggests these grafts could shorten hospital stays and improve recovery for people with challenging aortic conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Adam Beck, MD

Principal Investigator

University of Alabama at Bimingham

Are You a Good Fit for This Trial?

This trial is for stable patients with aortic pathologies like large aneurysms or ulcers near the visceral segment of the aorta. It's not for those under 18, pregnant, with severe allergies to contrast material, infections risking graft infection, poor X-ray visibility due to body shape, life expectancy under one year, or certain heart and artery conditions.

Inclusion Criteria

You have a deep penetrating ulcer in your aorta that is larger than 2.0cm.

My tumor has grown more than 0.5 cm in a year.

My condition causes symptoms or has led to a rupture.

Exclusion Criteria

Unwilling or unable to comply with the follow-up schedule

History of anaphylactic reaction to contrast material that cannot be adequately premedicated

The landing zone for the medical device is less than 20mm long.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive one of the investigational endografts, with procedures including Clinical Exam, Blood Tests, CT Scans, Abdominal Device X-ray, and Angiography

Procedure duration varies

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with assessments including Clinical Exam, Blood Tests, CT Scans, and Angiography

5 years

Regular visits (in-person)

12-Month Evaluation

Evaluation of treatment success, including procedural technical success and patent treated branch vessels

12 months post procedure

What Are the Treatments Tested in This Trial?

Interventions

• Cook Custom Aortic Endograft
• Surgeon-Modified Endograft
• Zenith t-Branch Endovascular Graft

Trial Overview The study compares three endovascular devices: Cook Custom Aortic Endograft, Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endografts in treating complex aortic issues that standard devices can't fix. The goal is to reduce hospital stays and complications.

How Is the Trial Designed?

Group I: Zenith t-Branch Endovascular Graft Experimental Treatment 1 Intervention

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the sizing of the the Zenith t-Branch Endovascular Graft. The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.

Group II: Surgeon-Modified Endograft Experimental Treatment 1 Intervention

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Surgeon-Modified Endografts. These will be created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.

Group III: Cook Custom Aortic Endograft Experimental Treatment 1 Intervention

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Cook Custom Aortic Endograft. The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.

Cook Custom Aortic Endograft is already approved in United States for the following indications:

Approved in United States as Cook Custom Aortic Endograft for:

• Thoracoabdominal aortic aneurysms
• Juxtarenal and suprarenal aortic aneurysms

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Cook Group Incorporated

Industry Sponsor

Trials

92

Recruited

15,500+

Carl Cook

Cook Group Incorporated

Chief Executive Officer since 2011

Bachelor's degree in Engineering from Purdue University, MBA from the University of Iowa

Dr. John A. Kaufman

Cook Group Incorporated

Chief Medical Officer since 2023

MD

Published Research Related to This Trial

In a study of 80 patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair with the Zenith t-Branch graft, technical success was achieved in 98.8% of cases, demonstrating the efficacy of this endovascular approach.

At 24 months, the study reported high rates of target vessel patency, with 94.8% for primary patency and 96.3% for secondary patency, indicating durable outcomes and safety in managing TAAA with this graft.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms. Tsilimparis, N., Bosiers, M., Resch, T., et al.[2023]

The Cook Zenith t-Branch multibranched endograft is a safe and effective option for urgent thoracoabdominal aortic aneurysm (TAAA) repairs, with a clinical success rate of 78% and manageable rates of spinal cord ischemia (17%) and 30-day mortality (14%).

Despite its effectiveness, the study highlights that patients with ruptured TAAAs have lower survival rates (52% at 1 year) compared to those with non-ruptured TAAAs (60%), indicating the need for careful patient selection in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urgent endovascular repair of thoracoabdominal aneurysms using an off-the-shelf multibranched endograft. Gallitto, E., Faggioli, G., Spath, P., et al.[2022]

Fenestrated and branched aortic endografts, like the Zenith T-Branch device, have improved treatment options for patients with extensive thoracoabdominal aortic aneurysms (TAAAs) by allowing for aneurysm exclusion while preserving blood flow to vital organs.

The development of 'off-the-shelf' grafts, such as the Zenith T-Branch, aims to provide quicker treatment options for patients in need, although long-term outcomes regarding their effectiveness and safety are still being studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update of T-branch use from the US Aortic Research Consortium. Khoury, MK., Lancaster, E., Eagleton, MJ., et al.[2023]

The t-Branch endograft demonstrated a high technical success rate of 92.75% in treating thoracoabdominal aortic aneurysms, making it a reliable option for both elective and urgent cases.

Early mortality was relatively low at 5.8%, and while there were some complications such as spinal cord ischemia (12.2%) and acute renal failure (18.7%), the overall outcomes suggest that the t-Branch endograft is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of published studies on endovascular repair of thoracoabdominal aortic aneurysms with the t-Branch off-the-shelf multibranched endograft. Konstantinou, N., Antonopoulos, CN., Jerkku, T., et al.[2020]

The off-the-shelf multibranched Zenith t-Branch endograft demonstrated a technical success rate of 82% in urgent thoracoabdominal aortic aneurysm (TAAA) repairs, indicating it is a viable option when custom-made grafts are not available.

Despite some complications, including a 6% 30-day mortality rate and temporary spinal cord ischemia in 6% of patients, the endograft showed promising long-term outcomes with no TAAA-related mortality and 82% freedom from reintervention at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-the-shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms. Gallitto, E., Gargiulo, M., Freyrie, A., et al.[2018]

The t-Branch stent graft is an effective off-the-shelf solution for treating rapidly expanding thoracoabdominal aortic aneurysms, allowing for intraoperative customization to accommodate individual patient anatomy.

In a case study involving a 66-year-old woman, the t-Branch stent graft successfully excluded the aneurysm sac and resulted in nearly complete shrinkage of the sac after 12 months, demonstrating its efficacy in urgent situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular repair of thoracoabdominal aortic aneurysm using the off-the-shelf multibranched t-Branch stent graft. Mendes, BC., Oderich, GS.[2017]

In a study involving 50 patients with blunt thoracic aortic injury, the Zenith Alpha thoracic endovascular graft demonstrated a low 30-day mortality rate of 2%, with a high rate of aortic injury healing at 96% after 2 years.

Despite the overall safety and effectiveness, the study found thrombus formation in 30% of patients, leading to the manufacturer's decision to remove the device's indication for this specific injury, highlighting the need for careful device sizing and lifelong follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated outcomes from the TRANSFIX study to evaluate endovascular repair of blunt thoracic aortic injuries with the Zenith Alpha thoracic device. Starnes, BW., Dwivedi, A., Giglia, J., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02043691

Evaluation of the Cook Custom Aortic Endograft, the Zenith ... This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/569735

Evaluation of the Cook Custom Aortic Endograft, the Zenith ... This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, ...

3. jvascsurg.org jvascsurg.org/article/S0741-5214(21)00323-2/fulltext

Early and midterm results from a postmarket observational ... The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521425000217

T-branch by partial deployment technique in the ... Aim of this study was to report outcomes of the endovascular repair of complex aortic (c-AAAs) and thoracoabdominal (TAAAs) aneurysms by T-branch and PDT.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21459545/

Long-term results after endovascular abdominal aortic ... Conclusion: Elective EVAR using the Cook Zenith endograft provides excellent results through a mean follow-up of >5 years. There is a low aneurysm-related ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092505/

Midterm Outcomes for Endovascular Repair of Thoraco- ... To investigate technical and clinical outcomes in patients with thoraco-abdominal aortic aneurysms treated with the multibranched off the shelf Zenith t-Branch ...