Aortic Endografts for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Overseen by Adam Beck, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Infection, Renal failure, others

No Placebo Group

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alabama at Birmingham Birmingham, AL

Who Is Running the Clinical Trial?

University of Alabama at Birmingham Lead Sponsor

Cook Group Incorporated Industry Sponsor

References

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

Off-the-shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms. [2018] The aim of this paper was to report early and midterm results of endovascular repair of urgent thoracoabdominal aortic aneurysms (TAAAs) by the off-the-shelf multibranched Zenith t-Branch endograft (Cook Medical, Bloomington, Ind).

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] The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe).

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

Update of T-branch use from the US Aortic Research Consortium. [2023] Aortic endograft evolution has altered our approach to treating patients with both standard and complex aortic disease. In particular, fenestrated and branched aortic endografts have allowed for the expansion of therapy to include those patients with extensive thoracoabdominal aortic aneurysms (TAAAs). The fenestrations and branches allow for the aortic endografts to achieve a seal in the proximal and distal aspects of the aorto-iliac tree, to exclude the aneurysm, while maintaining perfusion to the renal and visceral vessels. Historically, many of the grafts used for this purpose are custom made devices designed for a specific patient based on their preoperative computed tomography imaging. One downside to this approach is the time it takes to construct these grafts. Given this, much effort has been directed towards developing "off-the-shelf" grafts which may be applicable to many patients in an immediate-need bases. The Zenith T-Branch device offers an off-the-shelf graft with four directional branches. Its utilization is not applicable to all patients, but can be applied to many patients with TAAAs. Large reported series on outcomes for these devices is limited to centers in Europe as well as within the United States Aortic Research Consortium. While early outcomes appear excellent, long-term outcomes related to aneurysm exclusion, branch patency, and freedom from reintervention are needed and will be forthcoming.

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

Urgent endovascular repair of thoracoabdominal aneurysms using an off-the-shelf multibranched endograft. [2022] Our goal was to report outcomes of the endovascular repair of urgent thoracoabdominal aortic aneurysms (TAAAs) using the Cook Zenith t-Branch off-the-shelf multibranched endograft.

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] Endovascular repair has been increasingly used to treat thoracoabdominal aortic aneurysms using patient-specific or off-the-shelf fenestrated and branched stent grafts. Device customization limits the application of patient-specific devices in patients who need urgent or emergency repair because of ruptured or large, rapidly expanding aneurysms. For these patients, an off-the-shelf multibranched stent graft, the t-Branch stent graft (Cook Medical, Bjaeverskov, Denmark) has been developed based on the relative predictability of visceral vessel anatomy, allowing incorporation and intraoperative customization of target vessels with four down-going directional branches. We used the t-Branch stent graft in a 66-year-old woman with a rapidly enlarging type III thoracoabdominal aortic aneurysm. Completion angiography and follow-up computed tomography angiography demonstrated successful exclusion of the aneurysm sac, patent target vessels, and nearly complete sac shrinkage at the 12-month follow-up.

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] Endovascular treatment of thoracoabdominal aortic aneurysms is becoming increasingly popular in clinical practice, mainly because of its reduced perioperative mortality and morbidity. However, the custom-made stent graft platform that companies offer requires detailed preoperative planning and production time that can take up to 12 weeks. This may delay surgery in elective patients and is not an option for urgent or emergent cases. To surpass this limitation, the t-Branch (Cook Medical, Bloomington, Ind) was launched in 2012 in Europe as the first off-the-shelf standardized multibranched endograft for the endovascular treatment of thoracoabdominal aneurysms. Our aim was to systematically evaluate all published experience with this commercially available off-the-shelf thoracoabdominal stent graft.

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] The purpose of this study was to report the updated results of a prospective, multicenter, nonrandomized, single-arm investigational device exemption study conducted at 17 sites in the United States to assess safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injury (BTAI).