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

Trial Summary

What is the purpose of this trial?

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 Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving the visceral vessels. The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.

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 data supports the idea that Aortic Endografts for Aortic Aneurysm is an effective treatment?

The available research shows that Aortic Endografts, like the Zenith t-Branch, are effective for treating thoracoabdominal aortic aneurysms. Studies report successful outcomes in urgent cases, with the endografts helping to exclude the aneurysm and maintain blood flow to important vessels. For example, one study showed that after using the t-Branch endograft, a patient's aneurysm shrank significantly within a year. This suggests that the treatment can be effective, especially in urgent situations where custom devices are not feasible. ^{1 2 3 4 5}

What safety data is available for aortic endografts used in aortic aneurysm treatment?

The safety data for aortic endografts, particularly the Zenith t-Branch endograft, indicates that these devices are increasingly used for the endovascular repair of thoracoabdominal aortic aneurysms (TAAAs). Studies have shown that the t-Branch endograft, an off-the-shelf multibranched device, is effective for urgent cases due to its immediate availability, bypassing the long production time required for custom-made grafts. Early and midterm results suggest reduced perioperative mortality and morbidity, although long-term outcomes related to aneurysm exclusion, branch patency, and freedom from reintervention are still being evaluated. The device has been used in both Europe and the United States, with promising early outcomes reported by the US Aortic Research Consortium. ^{1 3 4 6 7}

Is the Cook Custom Aortic Endograft a promising treatment for aortic aneurysms?

Yes, the Cook Custom Aortic Endograft, specifically the Zenith t-Branch Endovascular Graft, is a promising treatment for aortic aneurysms. It is an 'off-the-shelf' solution, meaning it is ready-made and can be used quickly, which is important for urgent cases. It has shown good early results in treating complex aortic aneurysms by effectively sealing the aneurysm and maintaining blood flow to important arteries. This makes it a valuable option for many patients with thoracoabdominal aortic aneurysms. ^{1 2 3 4 5}

Research Team

Adam Beck, MD

Principal Investigator

University of Alabama at Bimingham

Eligibility Criteria

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 condition involves a growth larger than 5.5 cm, or it has grown more than 0.5 cm in 6 months.

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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

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

Off-the-shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms. [2018]

2. United States 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. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Update of T-branch use from the US Aortic Research Consortium. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Urgent endovascular repair of thoracoabdominal aneurysms using an off-the-shelf multibranched endograft. [2022]

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

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

6. United States 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. [2020]

7. United States 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. [2020]