Endovascular Stent-Graft for Aortic Aneurysm

Recruiting at 1 trial location

Overseen By Linda M Reilly, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Warren J. Gasper, MD

Disqualifiers: Pregnancy, Serious infection, Coagulopathy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating aortic aneurysms, which are dangerous bulges in the main artery. The treatment involves placing a special tube, called an endovascular branched stent-graft, inside the artery for support. The study aims to determine the safety and effectiveness of this method. Candidates for the trial have aortic aneurysms larger than a certain size, particularly if the aneurysm is rapidly enlarging. As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this endovascular stent-graft is safe for treating aortic aneurysms?

Research has shown that the endovascular branched stent-graft is generally safe and well-tolerated. This procedure places a special tube inside the artery to treat complex aortic aneurysms, helping to prevent the artery from bursting.

One study found that patients who underwent this procedure experienced low rates of complications, such as kidney issues or problems with blood flow to the spinal cord, within 30 days. Another study indicated that even older patients handled the procedure well, suggesting it is safe for many people.

Overall, these findings suggest that the endovascular branched stent-graft is a promising option for those with complex aortic aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Endovascular Branched Stent-Graft is unique because it offers a minimally invasive option for treating aortic aneurysms, which traditionally require open surgery. Unlike conventional methods that involve large incisions and longer recovery times, this stent-graft is delivered through small incisions in the groin and arm, using tubes inserted into the femoral and brachial arteries. Researchers are excited about this approach because it can potentially reduce recovery time and lower the risk of complications associated with more invasive procedures, making it a promising alternative for patients who may not be ideal candidates for open surgery.

What evidence suggests that the Endovascular Branched Stent-Graft is effective for aortic aneurysms?

Research has shown that using branched stent-grafts inside blood vessels effectively treats complex aortic bulges, known as aneurysms. In this trial, participants will receive the Endovascular Branched Stent-Graft, which researchers are investigating for safety and effectiveness. Studies have found that this method is safe and effective, even for older adults. Specifically, these stent-grafts help prevent the aneurysm from worsening. Evidence indicates that patients experience good early and midterm results after the procedure. Overall, this treatment offers a promising option for patients with hard-to-treat aortic aneurysms. ^{1 2 5 6 7}

Who Is on the Research Team?

Warren J Gasper, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willingness to comply with follow-up schedule

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

My aortic aneurysm is at least 5.5 cm wide.

Exclusion Criteria

I have a blood clotting disorder that cannot be corrected.

Pregnancy

Known allergy to Nitinol, stainless steel, or polyester

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular treatment involving the placement of a stent-graft over the aortic aneurysm

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the endovascular treatment

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular Branched Stent-Graft

Trial Overview

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.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 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).

Endovascular Branched Stent-Graft is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Fenestrated Endovascular Aneurysm Repair (FEVAR) for:

• Thoracoabdominal aortic aneurysms (TAAAs)
• Paravisceral abdominal aortic aneurysms (PVAAAs)

Approved in United States as Branched Endovascular Aneurysm Repair (BEVAR) for:

• Thoracoabdominal aortic aneurysms (TAAAs)
• Paravisceral abdominal aortic aneurysms (PVAAAs)

Approved in Canada as Endovascular Aneurysm Repair (EVAR) for:

• Abdominal aortic aneurysms (AAAs)
• Thoracoabdominal aortic aneurysms (TAAAs)

Who Is Running the Clinical Trial?

Warren J. Gasper, MD

Lead Sponsor

Trials

1

Recruited

250+

Timothy Chuter, MD

Lead Sponsor

Trials

2

Recruited

280+

Published Research Related to This Trial

A systematic review of 29 studies involving 693 cases of branched and fenestrated endografts (fEVAR/bEVAR) showed a high technical success rate of 96% in treating thoracic aorta pathologies, primarily aneurysms and dissections.

The main complications included a 5.2% rate of endoleaks and a 4.8% rate of strokes, with an in-hospital mortality of 2.5%, indicating that while these techniques are effective, there are notable risks that need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Initial Experience on Branched and Fenestrated Endografts in the Aortic Arch. A Systematic Review. Blanco Amil, CL., Mestres Alomar, G., Guarnaccia, G., et al.[2021]

In a study of 8 urgent cases of endovascular aneurysm repair using physician-modified grafts, there was a 100% technical success rate and no procedure-related complications, indicating a high level of safety for this approach.

The study showed that physician-modified FEVAR can be a viable alternative to traditional open surgery, with a 14% rate of endoleak and a 0% 30-day mortality rate, suggesting effective management of complex aortic aneurysms in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-Modified Fenestrated Endografts for Managing the Ruptured or Symptomatic Aortic Aneurysm: Technique Overview and Clinical Outcomes. Singh, A., Mafeld, S., Williams, R., et al.[2018]

In a study of 39 patients treated with the BeGraft stent graft system for fenestrated endovascular aneurysm repair (fEVAR), the bridging stents showed high patency rates of 98% at 1 year and 97% at 2 years, indicating effective long-term performance.

Despite a 28% mortality rate during follow-up, primarily from non-aneurysm-related causes, the BeGraft stents demonstrated a 96% freedom from secondary procedures, suggesting that they are a reliable option for connecting stent grafts to aortic branch vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm Outcomes of BeGraft Stent Grafts Used as Bridging Stents in Fenestrated Endovascular Aortic Aneurysm Repair. Clough, RE., Spear, R., Mougin, J., et al.[2023]

In a study of 100 patients undergoing fenestrated or branched endovascular aortic repair (FEVAR/BEVAR), the primary technical success rate was 87%, indicating that this method is generally effective for treating complex aortic aneurysms.

The 30-day mortality rate was 6%, primarily due to myocardial infarction, emphasizing the need for careful preoperative risk assessment to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated and branched endovascular repair for juxtarenal and thoracoabdominal aortic aneurysms: analysis of the first 100 cases. Uijtterhaegen, G., VAN Langenhove, K., Moreels, N., et al.[2022]

Fenestrated and branched endovascular aneurysm repair (F/BEVAR) after open surgical repair (OSR) of abdominal aortic aneurysms shows a high technical success rate of 96% and low 30-day mortality of 2%, indicating it is a safe option for reintervention.

During follow-up, aorta-related mortality was very low at 1%, and the reintervention rate was 16%, suggesting that F/BEVAR is effective in managing complications after OSR while maintaining patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis on fenestrated or branched devices after previous open surgical aortic aneurysm repair. Nana, P., Spanos, K., Apostolidis, G., et al.[2023]

Fenestrated (fEVAR) and branched (bEVAR) stent graft procedures show promising outcomes, with fEVAR having a low perioperative mortality rate of 0-4% and a high stent patency rate of 93-98% in visceral vessels, making it a viable alternative to open surgery for abdominal aortic aneurysms.

However, bEVAR procedures have higher mortality rates (4-7%) and a greater incidence of spinal cord ischemia (4-13%), highlighting the need for careful patient selection and interdisciplinary decision-making when choosing between endovascular and surgical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated and Branched Aortic Grafts. Rylski, B., Czerny, M., Südkamp, M., et al.[2018]

A 62-year-old male patient with a 63-mm juxtarenal aortic aneurysm successfully underwent a 6-fold fenestrated endovascular aortic repair (FEVAR), cannulating four renal arteries and two major abdominal arteries without any perioperative complications or renal function impairment.

After 12 months of follow-up, the patient maintained normal renal function, and the endograft showed good fit with no endoleaks and a reduction in aneurysm diameter, suggesting that 6-fold FEVAR is a promising option for complex aortic aneurysms involving accessory renal arteries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Twelve-month Patency of a Six-fold Fenestrated Stent Graft for Type IV Thoracoabdominal Aneurysm Repair. Kalder, J., Gombert, A., Kotelis, D., et al.[2020]

In a study of 173 patients undergoing fenestrated endovascular aneurysm repair (FEVAR) for juxtarenal aortic aneurysms, the procedure showed a high technical success rate of 95.4% and a median survival of 7.1 years, indicating its long-term efficacy.

However, the use of more complex stent-grafts with three or four fenestrations was associated with a higher in-hospital mortality rate (8% vs. 2%) and increased risk of graft-related endoleaks, suggesting that while FEVAR is effective, careful consideration of graft design is important for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of fenestrated endovascular repair for juxtarenal aortic aneurysm. Roy, IN., Millen, AM., Jones, SM., et al.[2018]

Citations

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The purpose of this study was to evaluate the use of PM-F/BEVAR in patients with prior failed EVAR.

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The aim of this study was to evaluate aortic-related mortality (ARM) and aortic aneurysm rupture after FB-EVAR of TAAAs.