Endovascular Stent Grafts for Aortic Aneurysm

Recruiting at 1 trial location

Overseen By Kiera Zehner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Darren Schneider, M.D.

Disqualifiers: Pregnancy, Infection, Connective tissue disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative

370 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

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 Stent Grafts for Aortic Aneurysm?

Research shows that fenestrated and branched stent grafts (F/BEVAR) are widely used and well-documented for treating complex aortic aneurysms, becoming the first choice for many patients due to their less invasive nature compared to open surgery. These techniques have been shown to be effective in maintaining blood flow to important arteries while repairing the aneurysm. ^{1 2 3 4 5}

Is endovascular stent grafting for aortic aneurysms generally safe for humans?

Endovascular stent grafting, including fenestrated and branched techniques, has been widely used and studied for treating complex aortic aneurysms. Studies have shown it to be a feasible and popular alternative to open surgery, with reported safety and clinical outcomes, although it is complex and should be performed in specialized centers. ^{1 2 5 6 7}

How is the endovascular treatment for aortic aneurysms different from other treatments?

The endovascular treatment for aortic aneurysms using fenestrated and branched stent grafts is unique because it offers a minimally invasive alternative to open surgery, allowing for the repair of complex aneurysms by fitting custom-made grafts to the patient's specific anatomy. This approach can be technically demanding but avoids the large incisions and longer recovery times associated with traditional surgery. ^{1 2 8 9 10}

Research Team

Darren Schneider, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults with thoracoabdominal aortic aneurysms (TAAA) that are large or growing quickly, and who are at high risk for open surgery. Candidates must have a life expectancy over 2 years, be able to consent and follow the study plan, and have suitable anatomy for the treatment. Pregnant women, those under 18, patients with certain allergies or conditions like Marfan Syndrome can't join.

Inclusion Criteria

You are expected to live for more than 2 years.

Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol

I am a woman with a rapidly growing TAAA larger than 4.5 cm.

Exclusion Criteria

Pregnancy or breastfeeding

I am under 18 years old.

I have a blood clotting disorder that cannot be corrected.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular stent graft implantation using either a multibranched stent graft or custom-manufactured physician-specified branched and/or fenestrated stent graft to treat aortic aneurysms

Intraoperative

Initial Follow-up

Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, and bowel infarction following deployment of the branched stent-graft

30 days

Long-term Follow-up

Participants are monitored for safety and effectiveness, including freedom from aneurysm-related mortality, stroke, hemodialysis, and other adverse events

Yearly through 5 years

Treatment Details

Interventions

• Endovascular treatment of Aortic Arch Aneurysms
• Endovascular treatment of Thoracoabdominal Aortic Aneurysm

Trial Overview The study tests endovascular treatments using special stent grafts on complex aortic aneurysms in two groups: one with TAAA and another with aortic arch aneurysms. It's not randomized; participants aren't chosen by chance but based on their condition suitability.

Participant Groups

Group I: TAAA (thoracoabdominal aortic aneurysm) Study Arm Experimental Treatment 1 Intervention

Either the Off-the-Shelf TAAA device or the Physician-Specified TAAA Device will be implanted. The Off-the-Shelf TAAA Device is a standard configuration Zenith t-Branch with four branches for the mesenteric arteries and the renal arteries. The Physician-Specified TAAA Devices may include a combination of up to 5 fenestrations and branches for mesenteric and renal arteries. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.

Group II: Aortic Arch Study Arm Experimental Treatment 1 Intervention

Physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery\] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.

Endovascular treatment of Aortic Arch Aneurysms is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Fenestrated and Branched Stent Grafts for:

• Thoracoabdominal Aortic Aneurysms
• Aortic Arch Aneurysms

Approved in United States as Fenestrated and Branched Stent Grafts for:

• Thoracoabdominal Aortic Aneurysms
• Aortic Arch Aneurysms

Approved in Canada as Fenestrated and Branched Stent Grafts for:

• Thoracoabdominal Aortic Aneurysms
• Aortic Arch Aneurysms

Who Is Running the Clinical Trial?

Darren Schneider, M.D.

Lead Sponsor

Trials

1

Recruited

370+

Findings from Research

In a study of 175 patients undergoing fenestrated/branched endovascular aortic repairs (F-BEVAR), those with inner branch configurations showed a high technical success rate of 94.1% and 100% primary inner branch patency at 30 days, indicating effective incorporation of target vessels.

Despite the high-risk nature of the patients, with many having significant comorbidities, there were no device-related mortalities, and overall survival at a mean follow-up of 5.8 months was 94%, suggesting that inner branch configurations are a safe alternative for complex aortic repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Inner Branches During Physician-Modified Endografting for Complex Abdominal and Thoracoabdominal Aortic Aneurysms. Pyun, AJ., Zhang, LL., Magee, GA., et al.[2022]

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]

Fenestrated and branched endovascular stent grafts (F/BEVARs) have become the preferred treatment for extended thoracoabdominal aortic aneurysms (TAAAs) in high- and moderate-risk patients, showing widespread acceptance in vascular centers over the past fifteen years.

Despite the popularity of F/BEVARs, there is currently no randomized study directly comparing open repair (OR) with F/BEVAR, leading to treatment decisions being largely based on physician preference and hospital expertise rather than solid comparative evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Immediate, Medium, and Long-Term Postoperative Results of Open Surgery and Fenestrated/Branched Stent Grafts for Extended Thoracoabdominal Aortic Aneurysms. Cochennec, F., Couture, T., Chiche, L.[2023]

The development of fenestrated and branched endovascular aneurysm repair (F-EVAR, B-EVAR) techniques allows for less invasive treatment options for complex aortic pathologies, which traditionally required more risky open surgeries.

Custom-made endografts tailored to individual patients' anatomy are becoming increasingly important, as they can improve outcomes for challenging cases like thoracoabdominal aortic aneurysms (TAAA), which are associated with high morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aortic Aneurysm: Fenestrated/Branched Endovascular Aortic Repair (EVAR) and Fenestrated/Branched Thoracic Endovascular Aortic Repair (TEVAR). Is Total Endovascular Repair Already Here?] Mehmedovic, A., Konstantinou, N., Jerkku, T., 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 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]

In a study of 243 patients treated with fenestrated and branched endovascular aneurysm repair (f/bEVAR), the 30-day survival rate was 96% and the 2-year survival rate was 80%, indicating that f/bEVAR is a viable treatment option even for patients aged 80 and older.

However, the study found that older patients (≥80 years) had a significantly lower 2-year survival rate (62%) compared to younger patients (82%), particularly if they had comorbidities like chronic obstructive pulmonary disease (COPD) or chronic renal failure (CRF), which were identified as independent predictors of late mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Survival in Patients Over 80 Years Old Treated with Fenestrated and Branched Endograft. Pini, R., Faggioli, G., Gallitto, E., et al.[2020]

The study reviewed over 100 cases of branched and fenestrated stent-graft repairs for complex aortic aneurysms, highlighting the technical challenges and complications associated with this endovascular approach, such as stent-graft dislocation and vessel occlusion.

Based on their experience, the authors propose several modifications to the technique that could enhance the outcomes of these complex endovascular repairs, aiming to reduce the need for secondary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pararenal and thoracoabdominal aortic aneurysm repair with fenestrated and branched endografts: lessons learned and future directions. Austermann, M., Donas, KP., Panuccio, G., et al.[2016]

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 new endovascular technique using a fenestrated stent-graft was successfully performed on a 75-year-old man with a 5.5-cm thoracic aortic arch aneurysm, allowing for targeted blood flow to critical arteries while occluding the left subclavian artery.

At 8 months post-procedure, the patient showed no signs of the aneurysm and maintained proper blood flow to the necessary branches, indicating that this technique is both effective and safe for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular repair of a thoracic arch aneurysm with a fenestrated stent-graft. Yuan, L., Feng, X., Jing, Z.[2014]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Use of Inner Branches During Physician-Modified Endografting for Complex Abdominal and Thoracoabdominal Aortic Aneurysms. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Fenestrated and Branched Aortic Grafts. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Immediate, Medium, and Long-Term Postoperative Results of Open Surgery and Fenestrated/Branched Stent Grafts for Extended Thoracoabdominal Aortic Aneurysms. [2023]

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

[Aortic Aneurysm: Fenestrated/Branched Endovascular Aortic Repair (EVAR) and Fenestrated/Branched Thoracic Endovascular Aortic Repair (TEVAR). Is Total Endovascular Repair Already Here?] [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Italy pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of Survival in Patients Over 80 Years Old Treated with Fenestrated and Branched Endograft. [2020]

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

Pararenal and thoracoabdominal aortic aneurysm repair with fenestrated and branched endografts: lessons learned and future directions. [2016]

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

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

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

Endovascular repair of a thoracic arch aneurysm with a fenestrated stent-graft. [2014]