What side effects are associated with this type of intervention?

The most common side effects of endovascular treatments for Thoracoabdominal Aortic Aneurysms (TAAA), such as stent-graft procedures, include endoleak, device migration, and stent-graft collapse or infolding. Patients may also experience retrograde aortic dissection, which is a serious complication. Neurological risks include spinal cord ischemia, potentially leading to paraplegia. Additionally, there is a risk of renal impairment due to the contrast agents used during the procedure.

What prior FDA approvals exist?

The FDA has approved several endovascular stent-grafts for the treatment of Thoracoabdominal Aortic Aneurysms (TAAA). These devices, such as the Gore TAG Thoracic Endoprosthesis and the Medtronic Valiant Thoracic Stent Graft, are designed to reinforce the aortic wall and prevent aneurysm rupture. These stent-grafts are placed within the aorta to exclude the aneurysm from blood flow, thereby reducing the risk of rupture. The approval of these devices is based on their demonstrated safety and effectiveness in clinical trials, similar to the ongoing studies assessing new stent-graft technologies.

What other types of research exist?

One promising novel alternative to stent-grafts for TAAA is the use of multilayer stents. These stents have shown potential in safely excluding thoracoabdominal lesions while maintaining blood flow to vital branches. Another emerging approach is the hybrid technique, which combines open surgical debranching of vital arteries with endovascular stent-grafting. This method aims to improve outcomes by ensuring adequate blood flow to critical organs while reinforcing the aortic wall. Both techniques are being refined and have shown encouraging results in recent studies.

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Stent-Graft

Endovascular Stent-Graft for Aortic Aneurysm

N/A

Recruiting

Led By Warren J Gasper, MD

Research Sponsored by Timothy Chuter, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aortic aneurysms: greater than or equal to 6 cm in diameter in men

Aortic aneurysms: greater than or equal to 5.5 cm in diameter in women

Must not have

Uncorrectable coagulopathy

Free rupture of the aneurysm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a stent-graft may help treat aortic aneurysms.

Who is the study for?

This trial is for men and women with large aortic aneurysms (5.5 cm or more in diameter for women, 6 cm or more for men) including those that are growing quickly or have associated iliac aneurysms. Participants should expect to live at least two years, be able to consent, follow the study plan, and have suitable anatomy for the procedure. Pregnant individuals, those allergic to certain metals or materials used in stents, with uncontrolled bleeding disorders or serious infections cannot join.

What is being tested?

The trial tests a new endovascular treatment using a branched stent-graft placed over thoracoabdominal and paravisceral abdominal aortic aneurysms. It aims to evaluate how safe and effective this minimally invasive operation is compared to traditional surgery.

What are the potential side effects?

Potential side effects may include complications related to the placement of the stent such as blood vessel damage, infection risk at the insertion site, allergic reactions to stent materials like Nitinol or polyester, clotting issues around the graft area leading possibly leading to further interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man with an aortic aneurysm 6 cm or larger.

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My aortic aneurysm is at least 5.5 cm wide.

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My aortic aneurysm is larger than 5 cm and growing quickly.

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I have an iliac aneurysm larger than 4 cm.

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My arteries are suitable for a minimally invasive surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder that cannot be corrected.

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My aneurysm has burst.

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I currently have a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionalExperimental Treatment1 Intervention

Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Thoracoabdominal Aortic Aneurysms (TAAA) is endovascular stent-grafting. This procedure involves placing a stent-graft within the aorta to reinforce the vessel wall and prevent aneurysm rupture. The stent-graft acts as a scaffold, providing structural support to the weakened area of the aorta, thereby reducing the risk of rupture. This is crucial for TAAA patients because the aneurysm's location involves critical arteries supplying blood to major organs. By reinforcing the aorta, the stent-graft helps maintain blood flow and reduces the likelihood of life-threatening complications.

Treatment of thoracoabdominal aortic aneurysms with a combined endovascular and surgical approach.Impact of endovascular repair on open aortic aneurysm surgical training.