Endovascular Stent-Graft for Aortic Aneurysm

Recruiting at1 trial location

Overseen by Warren J Gasper, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Warren J. Gasper, MD

Disqualifiers: Pregnancy, Serious infection, Coagulopathy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Endovascular Branched Stent-Graft, Fenestrated Endovascular Aneurysm Repair (FEVAR), Branched Endovascular Aneurysm Repair (BEVAR), Endovascular Aneurysm Repair (EVAR)?

Research shows that fenestrated and branched endovascular repairs (FEVAR and BEVAR) are effective for treating complex aortic aneurysms, such as those near the kidneys or involving the thoracic aorta. These techniques have been shown to be safe and feasible, with studies reporting positive midterm and long-term outcomes. ^{1 2 3 4 5}

Is the endovascular stent-graft for aortic aneurysm generally safe for humans?

Research shows that endovascular stent-grafts, including fenestrated and branched types, are generally safe for treating aortic aneurysms, with studies reporting on technical success and manageable risks like acute kidney injury and spinal cord issues. These procedures are considered alternatives to open surgery, especially for complex cases, and have been evaluated for safety and feasibility in various studies. ^{1 2 4 6 7}

How is the Endovascular Branched Stent-Graft treatment different from other treatments for aortic aneurysms?

The Endovascular Branched Stent-Graft treatment is unique because it uses a minimally invasive approach to repair complex aortic aneurysms by inserting a stent (a small mesh tube) with branches or openings (fenestrations) that allow blood flow to important arteries, unlike traditional open surgery which requires a large incision. ^{1 2 3 4 8}

Research Team

Warren J Gasper, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Endovascular Branched Stent-Graft (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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Fenestrated and branched endovascular repair for juxtarenal and thoracoabdominal aortic aneurysms: analysis of the first 100 cases. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The Initial Experience on Branched and Fenestrated Endografts in the Aortic Arch. A Systematic Review. [2021]

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

Midterm Outcomes of BeGraft Stent Grafts Used as Bridging Stents in Fenestrated Endovascular Aortic Aneurysm Repair. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and Twelve-month Patency of a Six-fold Fenestrated Stent Graft for Type IV Thoracoabdominal Aneurysm Repair. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up of fenestrated endovascular repair for juxtarenal aortic aneurysm. [2018]

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

Systematic review and meta-analysis on fenestrated or branched devices after previous open surgical aortic aneurysm repair. [2023]

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

Physician-Modified Fenestrated Endografts for Managing the Ruptured or Symptomatic Aortic Aneurysm: Technique Overview and Clinical Outcomes. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Fenestrated and Branched Aortic Grafts. [2018]