Modified Aortic Endograft for Aortic Aneurysm

Not currently recruiting at 1 trial location

Overseen By Allison J Hawke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Oral antiplatelets

Disqualifiers: Connective tissue disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: 31

Duration: Day of Surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating thoracoabdominal aortic aneurysms (a dangerous bulge in a major artery) using a modified aortic endograft (a type of stent). The researchers aim to determine if this method is safer and more effective than traditional open surgery. Participants should have an aortic aneurysm that meets specific size criteria and be considered high-risk for standard surgery. Those with a large, asymptomatic aortic aneurysm who are not candidates for current treatments might be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a contraindication to oral antiplatelet therapy, you may not be eligible to participate.

What prior data suggests that this physician-modified aortic endograft is safe for treating thoracoabdominal aortic aneurysms?

Research has shown that specially modified endografts have successfully treated complex aortic aneurysms. These custom-made devices strengthen a weakened part of the aorta, the body's main artery.

Studies indicate that most patients tolerate these modified endografts well, typically without serious side effects. Common, less serious side effects might include minor discomfort or temporary issues at the placement site.

Evidence suggests these endografts are safer than traditional open surgery for aortic aneurysms. Open surgery requires a larger incision and longer recovery time, leading to more complications.

While this device is being tested for a specific type of aneurysm, it is based on endograft technology already used in other treatments, which can reassure regarding safety. However, like any medical treatment, risks exist. Participants should discuss these risks in detail with their healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the physician-modified aortic endograft because it offers a more tailored approach to treating aortic aneurysms compared to traditional open surgical repair. Unlike standard treatments, which often involve extensive surgery, this endograft is customized by physicians to fit the unique anatomy of the patient's aneurysm, potentially reducing recovery time and surgical risks. Additionally, the endovascular approach allows for the minimally invasive treatment of thoracoabdominal, thoracic, and abdominal aneurysms, expanding accessibility to patients who may not be candidates for open surgery. Overall, this innovative technique could lead to safer, more effective aneurysm management.

What evidence suggests that this physician-modified aortic endograft is effective for treating thoracoabdominal aortic aneurysms?

Research has shown that specially modified stents, known as endografts, have effectively treated complex bulges in the aorta, the body's main artery, for years. In this trial, participants will receive a physician-modified fenestrated endovascular graft, which effectively repairs thoracoabdominal aortic aneurysms. These endografts are customized for each patient to enhance fit and effectiveness. Patients have experienced positive outcomes with these specialized endografts, indicating a promising treatment option. ^{1 2 3 4 6}

Who Is on the Research Team?

David P. Kuwayama, M.D., M.P.A.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for men and women over 50 with thoracoabdominal aortic aneurysms who are high-risk candidates for open surgery and not suitable for FDA-approved endovascular grafts. Participants must be able to follow a five-year study plan, have life expectancy over two years, and meet size criteria for surgical repair.

Inclusion Criteria

The doctor thinks you are at high risk for a specific type of surgery.

My aneurysm is large enough to require surgery.

I have an aortic aneurysm that does not extend beyond my left subclavian artery.

Exclusion Criteria

I have unstable chest pain.

The area below the aneurysm is not long enough to support the stent.

You have a known condition that affects your connective tissues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular treatment using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft

Day of Surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for major adverse events and treatment success

5 years

Regular visits at 30, 183 days; 1, 2, 3, 4, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Physician-modified aortic endograft

Trial Overview The trial tests the safety and effectiveness of a modified Cook Zenith Alpha Thoracic Endovascular Graft in treating thoracoabdominal aortic aneurysms. It aims to show that this approach is as good or better than traditional open surgical replacement.

How Is the Trial Designed?

Group I: Main Arm - Physician-modified fenestrated endovascular graft Experimental Treatment 1 Intervention

Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.

Group II: Expanded Access Arm - Physician-modified fenestrated endovascular graft. Experimental Treatment 1 Intervention

Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal, thoracic, or abdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair in an expanded use population.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

David P. Kuwayama

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

In a study of 59 high-risk patients with pararenal and thoraco-abdominal aortic aneurysms, physician-modified endografts (PMEGs) achieved a high technical success rate of 96.6% and a 30-day mortality rate of only 5.1%, indicating their safety and efficacy as an alternative to open surgery.

During an average follow-up of 18.8 months, PMEGs demonstrated excellent primary branch patency (97.2%) and a high rate of aneurysm thrombosis (89.6%), with an overall survival rate of 94.9% at 6 months, suggesting promising long-term outcomes for patients unsuitable for conventional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of physician-modified endografts for the treatment of thoraco-abdominal and pararenal aortic pathologies at a single institution. Yang, G., Zhao, J., Zhang, L., et al.[2022]

A physician-modified endovascular graft (PMEG) demonstrated a high technical success rate of 98% in treating juxtarenal aortic aneurysms in 47 patients, many of whom were considered unsuitable for open surgery due to their health status.

The procedure showed a low in-hospital and 30-day mortality rate of 2%, with a freedom from aneurysm-related death also at 98%, indicating that PMEG is a safe and effective treatment option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. Starnes, BW.[2022]

The use of physician-modified endografts (PMEGs) with inner branches or fenestrations is effective for urgent treatment of complex aortic aneurysms, as demonstrated in two successful cases involving a 6.8 cm juxtarenal aneurysm and a contained rupture of the thoracoabdominal aorta.

Both procedures resulted in complete exclusion of the aneurysms and had uneventful postoperative recoveries, indicating that PMEGs can be a safe and viable option for managing complex aortic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. Torrealba, J., Panuccio, G., Kölbel, T., et al.[2022]

Physician modified endografts (PMEG) for treating thoraco-abdominal and complex abdominal aortic aneurysms showed a high technical success rate of 97.2%, indicating that this method is effective for endovascular aortic repair.

Major adverse events occurred in 15.5% of patients within 30 days, with a higher rate in urgent cases (24.6%) compared to elective cases (11.6%), suggesting that while PMEGs are generally safe, outcomes may vary based on the urgency of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Physician Modified Endografts for Treatment of Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms. Gouveia E Melo, R., Fernández Prendes, C., Caldeira, D., et al.[2022]

In a study involving 64 patients with juxtarenal aortic aneurysms, the use of physician-modified endovascular grafts (PMEGs) showed a high treatment success rate of 94.1% at 12 months, indicating their efficacy for patients unfit for open surgery.

The safety profile was also favorable, with a 30-day major adverse event rate of 11.9% and a mortality rate of 5.1%, suggesting that PMEGs are a viable option for high-risk patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. Starnes, BW., Heneghan, RE., Tatum, B.[2017]

In a study of 813 patients with thoracoabdominal aortic aneurysms (TAAAs), those who underwent repair with physician-modified endografts (PMEG) showed improved 1-year survival rates compared to those who had parallel grafting (PG), particularly in TAAA I-III repairs (85% vs 74%).

PMEG repairs also significantly reduced the occurrence of type Ia endoleaks, especially in TAAA IV cases (1.2% for PMEG vs 21.6% for PG), and were associated with lower rates of postoperative complications, indicating a safer and more effective approach for complex aneurysm repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms. Smith, JA., Sarode, AL., Stern, JR., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02989948

Physician-Modified Fenestrated and Branched Aortic ... The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ... Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06501872?cond=%22Aortic%20Aneurysm%22&aggFilters=status:not%20rec&rank=8

Safety and Effectiveness of Physician-Modified Fenestrated ... This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft base ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189729/

Early Financial Outcomes of Physician Modified Endograft ... Physician-modified endografts (PMEGs) have been used for repair of thoracoabdominal aortic aneurysms (TAAAs) for two decades with good outcomes ...

5. clinicaltrial.be clinicaltrial.be/en/details/72292?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Physician-Modified Fenestrated and Branched Aortic ... This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02989948/physician-modified-fenestrated-and-branched-aortic-endografting-for-taaa?activelyRecruiting=false&page=38&id=1027&slug=cardiovascular-disease

Physician-Modified Fenestrated and Branched Aortic ... The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic ...