Stent-Graft for Aortic Aneurysm

(IDE#2 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Gustavo S. Oderich, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Gustavo S. Oderich

Disqualifiers: Pregnancy, Infection, Connective tissue disorder, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participation in certain other clinical trials is restricted, so it's best to discuss your specific medications with the trial team.

What data supports the idea that Stent-Graft for Aortic Aneurysm is an effective treatment?

The available research shows that the Stent-Graft for Aortic Aneurysm, specifically the Zenith t-Branch, is effective in treating thoracoabdominal aortic aneurysms. Studies report positive early and midterm results, indicating that the treatment is safe and maintains blood flow in the targeted vessels for up to two years. This suggests that the Stent-Graft is a reliable option for managing this condition. ^{1 2 3 4 5}

What safety data is available for the Zenith t-Branch stent-graft used in aortic aneurysm treatment?

The safety data for the Zenith t-Branch stent-graft includes early and midterm results from various studies. A postmarket observational study reported short-term safety outcomes of the Zenith t-Branch multibranched thoracoabdominal stent-graft. Another study investigated midterm technical and clinical outcomes for patients treated with the Zenith t-Branch or a custom-made device. Additionally, a study assessed two-year clinical outcomes and target vessel patency following thoracoabdominal aortic aneurysm repair with the Zenith t-Branch. Early and midterm results were also reported for urgent repairs using the Zenith t-Branch endograft. ^{1 2 3 4 5}

Is the treatment Zenith t-Branch and customized physician-specified stent-graft a promising treatment for aortic aneurysm?

Yes, the Zenith t-Branch and customized physician-specified stent-graft is a promising treatment for aortic aneurysm. It offers a quick and effective solution for patients with complex aortic conditions, especially those needing urgent care. The device is designed to fit many patients without the long wait for a custom-made option, and early results show it successfully treats the aneurysm while keeping important blood vessels open. ^{1 2 3 6 7}

Eligibility Criteria

Adults with specific aortic aneurysms or dissections who are not pregnant, breastfeeding, or have a life expectancy under 2 years. They must be willing to follow the trial schedule and give consent. Exclusions include recent surgeries unrelated to the condition, participation in certain other trials, allergies to device materials, uncorrectable coagulopathy, active infections, certain connective tissue disorders.

Inclusion Criteria

My treatment may include a specific device for my lower torso condition.

My body can accommodate a specific device for my heart surgery.

I have an aneurysm in both my chest and upper stomach area.

Exclusion Criteria

You are expected to live for less than 2 years.

I need urgent repair for a ruptured aortic aneurysm, but it's stable and fits standard treatment designs.

You are not participating in any other experimental medical or device trials, except for specific trials related to endovascular stent-grafts or other approved medical therapies to reduce risks during fenestrated-branched endovascular repair.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular repair using the Zenith Fenestrated-Branched System to treat aortic aneurysms or dissections

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment success and quality of life measures

12 months

Multiple visits at 30 days, 6 months, 1 year

Long-term Follow-up

Extended monitoring of participants for quality of life and adverse events

5 years

Annual visits

Treatment Details

Interventions

• Zenith t-Branch and customized physician-specified stent-graft (Stent Graft)

Trial Overview The Zenith t-Branch and customized stent-graft systems are being tested for safety and effectiveness in repairing complex aortic aneurysms. These devices use fenestrations/branches designed for each patient's unique anatomy.

Participant Groups

Group I: Thoracoabdominal Aortic Aneurysm Arm Experimental Treatment 1 Intervention

The TAAA study arm will include patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Group II: Aortic Arch Aneurysm Arm Experimental Treatment 1 Intervention

Aortic Arch study arm will include patients with aortic arch aneurysms treated by Patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with thoracoabdominal and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator, including an off-the-shelf stent-graft (t-Branch stent-graft) or patient-specific stent-graft with a combination of fenestrations and/or branches.

Zenith t-Branch and customized physician-specified stent-graft is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Zenith t-Branch Thoracoabdominal Endovascular Graft for:

• Thoracoabdominal aortic aneurysms

🇺🇸 Approved in United States as Zenith t-Branch Thoracoabdominal Endovascular Graft for:

• Thoracoabdominal aortic aneurysms

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Texas Health Science Center at Houston Houston, TX

Mayo Clinic Rochester, MN

Who Is Running the Clinical Trial?

Gustavo S. Oderich Lead Sponsor

Gustavo Oderich Lead Sponsor

William Cook Australia Industry Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Midterm Outcomes for Endovascular Repair of Thoraco-Abdominal Aortic Aneurysms. [2022] To investigate technical and clinical outcomes in patients with thoraco-abdominal aortic aneurysms treated with the multibranched off the shelf Zenith t-Branch stent graft or a custom made device (CMD).

2. 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).

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

Use of the Off-the-Shelf t-Branch Device to Treat an Acute Type Ia Endoleak in a Symptomatic Juxtarenal Abdominal Aortic Aneurysm. [2016] To report the use of the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft for the treatment of a symptomatic acute type Ia endoleak subsequent to previous infrarenal bifurcated endovascular aneurysm repair.

4. 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).

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

Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. [2022] We have reported the short-term outcomes regarding the safety of the off-the-shelf Zenith t-Branch multibranched thoracoabdominal stent-graft (William Cook Europe ApS, Bjaeverskov, Denmark) in a postmarket, multicenter study.

6. 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.

7. 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.