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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new stent grafts, tube-like devices, to treat certain types of aortic aneurysms (bulges in the artery wall that may burst). The focus is on endovascular repair, a minimally invasive technique, for patients with complex aortic aneurysms at high risk for open surgery. One group will use devices for thoracoabdominal aortic aneurysms, and the other for aortic arch aneurysms. Suitable candidates include those with large or fast-growing aortic aneurysms who have been advised that traditional surgery is too risky. As an unphased trial, this study provides patients with access to innovative treatments not yet widely available.

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 these endovascular treatments are safe for aortic aneurysms?

Research has shown that treatments inside blood vessels for certain types of aortic aneurysms are generally well-tolerated. For thoracoabdominal aortic aneurysms (TAAA), studies have found that procedures were completed successfully without major issues like paralysis, kidney failure, stroke, or heart attacks in surviving patients. In one study, all patients had successful procedures, with everything proceeding as planned.

For aortic arch aneurysms, research indicates a low death rate around the time of the procedure. In one study, only 7% of patients experienced serious problems, such as the implanted device moving or having a stroke. Another study found that only 2% of patients died within 30 days after the procedure.

Overall, these treatments appear safe, with most patients not experiencing serious problems. However, like any medical procedure, some risks remain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a less invasive alternative to traditional open surgery for aortic aneurysms, which often involves significant risks and lengthy recovery times. The endovascular stent grafts allow for precise, customizable placement tailored to each patient's unique anatomy, particularly with options like the Off-the-Shelf TAAA Device and Physician-Specified TAAA Devices. These devices can accommodate various artery orientations thanks to their specific branch and fenestration designs. Additionally, the ability to specify branches and scallops in the aortic arch stent grafts offers a targeted approach for high-risk patients, potentially reducing complications compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for aortic aneurysms?

This trial will compare two separate endovascular treatments for aortic aneurysms. Studies have shown that a less invasive procedure called endovascular repair effectively treats thoracoabdominal aortic aneurysms, with a success rate of 93%. This method avoids open surgery, benefiting patients at higher risk. Participants in the TAAA Study Arm will receive either an Off-the-Shelf TAAA device or a Physician-Specified TAAA Device.

For aneurysms in the aortic arch, all patients survived at least six months, and 93.3% survived at least one year, demonstrating good early results. Participants in the Aortic Arch Study Arm will receive a physician-specified aortic arch stent graft device. This less invasive procedure has successfully reduced the size of the aneurysm. Overall, these treatments offer a safer option with strong success rates for patients who may not be suitable for traditional surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Darren Schneider, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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

I am under 18 years old.

Pregnancy or breastfeeding

Known sensitivities or allergies to specified materials

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 (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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666250725001725

Outcomes of fenestrated-branched endovascular aortic ... Patient survival was 100% at 6 months and 93.3% ± 16% at 1 year and 3 years. Aneurysm sac reduction >5 mm was observed in 7 (47%) patients. Five (33%) patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12347276/

Outcomes of fenestrated-branched endovascular aortic repair ... Patient survival was 100% at 6 months and 93.3% ± 16% at 1 year and 3 years. Aneurysm sac reduction >5 mm was observed in 7 (47%) patients. Five (33%) patients ...

3. jacc.org jacc.org/doi/10.1016/j.jaccas.2025.103954

Customized Fenestrated Single-Branched Stent Graft for ... We report the first successful placement of a customized fenestrated stent graft for treatment of an aortic arch aneurysm in China.

4. jvascsurg.org jvascsurg.org/article/S0741-5214(24)00931-5/fulltext

Branched and fenestrated endovascular aortic arch repair ... Technical success was 94.4%, and 30-day mortality was 11.9%. Strokes were diagnosed in 13.5% of patients and major strokes were identified in 7.9% cases.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5483394/

Outcomes of Thoracic Endovascular Aortic Repair Using ... Outcomes of these techniques have mixed results, with morbidity and mortality rates of 30–40% and 10–15%, respectively. Although branched/fenestrated arch ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37646117/

Safety and Efficacy of Inner Branched Stent-Graft in the ... Forty patients (6.5%; 95% CI=2.5%-9.5%) required early reintervention. During a mean follow-up of 20.7±13.5 months, the mortality rate was 18.2% ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1078588404005647

Endovascular Treatment of Aortic Arch Aneurysms Perioperative mortality was 2/30 (7%), due to graft migration (zone '2') and intra-operative stroke (zone '0'), respectively. One minor stroke was observed. No ...

8. mednexus.org mednexus.org/doi/10.1097/CD9.0000000000000080

Endovascular Management of Aortic Arch Diseases [27] In that study, the prevalence of an immediate type-Ia endoleak was 16%, 30-day mortality was 2%, and morbidity was 4%, and chimney-stent ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00583817

Endovascular Treatment of Thoracic Aortic Disease Arch Arm Protocol: The purpose of this study is to assess the safety, efficacy, and intermediate (or long-term) rupture free survival rate of high risk surgical ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38157994/

Outcomes of thoracic endovascular aortic repair with ... The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality. Keywords: Aortic arch pathologies; Partial ...