Modified Endografting for Aortic Aneurysm

Overseen By Caren Saunders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bjoern D. Suckow

Must not be taking: Oral antiplatelets

Disqualifiers: Connective tissue disorder, others

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

Compensation: Varies

Number of Visits: 2

Duration: Day of Surgery

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for thoracoabdominal aortic aneurysms, which are dangerous bulges in the body's main artery. It uses a special device called a physician-modified aortic endograft to determine if it is safer and more effective than traditional surgery. The trial includes two groups: one for individuals with specific types of aneurysms and another for those with a broader range of aneurysm issues. This trial may suit someone diagnosed with a large aortic aneurysm and considered high-risk for regular surgery. As an unphased trial, it provides patients access to innovative treatment options not yet widely available.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions a contraindication to oral antiplatelet therapy, which might suggest some restrictions. It's best to discuss your specific medications with the trial team.

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

Research shows that the physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft is undergoing testing for safety and effectiveness in treating aortic aneurysms. Previous studies have found that patients generally tolerate this treatment well. Negative side effects are similar to those expected with comparable procedures.

One study found that patients who received this modified device had outcomes similar to those from traditional surgery. This suggests the treatment is reasonably safe, though some risks accompany any medical procedure. It's important to note that this device modifies an already approved product, which adds confidence in its safety. However, individual experiences may vary, so discussing potential risks with a healthcare provider is crucial. ^{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 cutting-edge approach to treating thoracoabdominal aortic aneurysms. Unlike traditional open surgical repairs, which are invasive and require extended recovery times, this treatment uses a minimally invasive endovascular technique. The physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft is tailored to fit the unique anatomical features of each patient, potentially improving outcomes and reducing risks associated with standard procedures. This personalized approach could significantly enhance patient safety and recovery, making it a promising advancement in aneurysm treatment.

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

Research has shown that customized endografts, known as PMEGs, have effectively treated thoracoabdominal aortic aneurysms (TAAAs) for over 20 years. These endografts are specially designed to fit each patient, providing a safer and less invasive alternative to open surgery. Studies have reported positive outcomes in complex cases, with many patients experiencing successful repairs. In this trial, participants will receive the physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft, recognized for its effectiveness in challenging aneurysm repairs. Overall, evidence supports these modified endografts as a reliable choice for treating aortic aneurysms. ^{1 2 3 6 7}

Who Is on the Research Team?

Bjoern Suckow, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with thoracoabdominal aortic aneurysms (TAAAs) or pararenal aortic aneurysms. Participants should be suitable candidates for endovascular repair, meaning their anatomy must fit the criteria for using the modified graft and they need to be able to undergo the procedure.

Inclusion Criteria

Must commit to comply with the five-year study assessment schedule of events

Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years

Patient must be able to provide informed consent

Exclusion Criteria

Known connective tissue disorder

My imaging shows issues with the arteries needed for a specific medical device.

I have a major surgery planned within 30 days of my aneurysm repair.

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)

Initial Follow-up

Participants are monitored for immediate post-surgical outcomes and complications

30 days

1 visit (in-person)

Extended Follow-up

Participants are monitored for long-term safety and effectiveness of the treatment

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Physician-modified Aortic Endograft

Trial Overview The study is testing the safety and effectiveness of a custom-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft compared to traditional open surgical replacement in treating TAAAs.

How Is the Trial Designed?

Group I: Main Arm 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 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?

Bjoern D. Suckow

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

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 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]

The study involving 26 patients with juxtarenal aortic aneurysms showed that using a physician-modified endovascular graft (PMEG) is a safe procedure, with no major adverse events and only one minor complication reported during the 30-day follow-up.

PMEG demonstrated high efficacy, achieving treatment success in 87.5% of patients, with no cases of migration, rupture, or significant endoleaks, making it a promising option for patients unsuitable for open repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. Starnes, BW., Tatum, B.[2013]

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]

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. 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 Endogr... This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft base ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468428725002990

Utilization of Zenith Alpha Thoracic 2.0 to Facilitate ... In this report, we describe the use of the Zenith Alpha Thoracic 2.0 (ZTA2) (Cook Medical, Bloomington, IN) stent graft in the creation of a ...

5. 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 ...

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

Safety and Effectiveness of Physician-Modified Fenestrated ... The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic ...

7. trialx.com trialx.com/clinical-trials/listings/316641/safety-and-effectiveness-of-physician-modified-fenestrated-and-branched-aortic-endografting-for-the-treatment-of-thoracoabdominal-and-pararenal-aortic-aneurysms/

Safety and Effectiveness of Physician-Modified Fenestrated ... The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis ...