Endovascular Aneurysm Repair for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

Disqualifiers: Mycotic aneurysm, Ruptured aneurysm, Infection, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a custom-made device for high-risk patients with complex aneurysms near vital organs. The device is inserted through a minimally invasive procedure to reinforce blood vessel walls and ensure proper blood flow. It is designed for patients who cannot use standard treatments. The device has been customized for patient anatomy to treat complex aortic aneurysms.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA), Physician Modified Endograft, PMEG?

Research shows that physician-modified endografts (PMEG) are effective for treating complex aortic aneurysms, including thoraco-abdominal and complex abdominal types, especially in patients unsuitable for open surgery. Studies indicate PMEGs offer a survival benefit over other techniques like parallel grafting for thoracoabdominal aneurysms.

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Is endovascular aneurysm repair using physician-modified endografts generally safe for humans?

Research shows that physician-modified endovascular grafts (PMEGs) have been used safely in patients with complex aortic aneurysms who are not suitable for open surgery. These studies suggest that PMEGs are a safe option for treating certain types of aortic aneurysms.

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How is the Physician Modified Endograft treatment different from other treatments for aortic aneurysms?

The Physician Modified Endograft (PMEG) is unique because it is customized by doctors to fit the specific needs of patients with complex aortic aneurysms, especially those who cannot undergo open surgery. This approach allows for a more tailored and potentially safer treatment option compared to standard endovascular or open surgical methods.

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Eligibility Criteria

This trial is for high-risk patients over 18 with complex aortic aneurysms who can't use FDA-approved endografts but have suitable anatomy for a modified version. They must not be pregnant, have good vascular access, and agree to long-term follow-up. Excluded are those with infections, allergies to device materials, other serious health issues or conditions affecting the study participation.

Inclusion Criteria

My lower artery near the hip is long enough for a safe procedure.

I have a complex aneurysm in my upper abdomen or chest.

I am a man or a woman not currently pregnant (if capable of bearing children, I have a negative pregnancy test).

Exclusion Criteria

My doctor expects I have less than 2 years to live due to my cancer.

Aorta with a disorganized or irregular appearance.

You have a known severe allergic reaction to blood thinners or contrast dye that cannot be treated before the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Staged Procedure

A staged approach may be used to minimize risks associated with a single extensive repair, including ischemic conditioning and microembolization.

2-4 weeks prior to PMEG implantation

Treatment

Participants undergo PMEG implantation for complex aortic aneurysm repair using physician-modified endografts.

Procedural

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up at one month, six months, one year, and yearly thereafter.

5 years

Follow-up visits at 1 month, 6 months, 1 year, and annually

Participant Groups

The trial tests a physician-modified endograft on patients with complex aortic aneurysms. It aims to cover renal arteries and others in cases where standard options aren't viable. The study will enroll 40 subjects at one site over two years and follow them for five years, assessing safety within the first month and effectiveness after one year.

Group I: Physician-Modified Endograft Experimental Treatment 1 Intervention

This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysms (Extent I-V).

Physician Modified Endograft is already approved in United States for the following indications:

🇺🇸 Approved in United States as Physician Modified Endograft for:

• Complex aortic aneurysms
• Pararenal aortic aneurysms
• Juxtarenal aortic aneurysms
• Thoracoabdominal aortic aneurysms

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California San Diego San Diego, CA

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

References

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

Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. [2022] To determine if a physician-modified endovascular graft (PMEG) is a safe and effective method of treating juxtarenal aortic aneurysms in patients considered to be unsuitable for open surgical repair.

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

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. [2022] To describe the use of physician-modified endograft (PMEG) with the exclusive use of inner branches or in combination with fenestrations for the urgent treatment of complex aortic aneurysms.

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

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms. [2022] Physician-modified endografts (PMEG) and parallel grafting (PG) are important techniques for endovascular repair of complex aortic aneurysms using off-the-shelf devices. However, there are few data regarding the relative efficacy and outcomes of these techniques in thoracoabdominal extent aneurysms. This study sought to compare the outcomes of PG and PMEG across different extents of thoracoabdominal aneurysms (TAAAs) for which they can be used.

4. England pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Physician Modified Endografts for Treatment of Thoraco-Abdominal and Complex Abdominal Aortic Aneurysms. [2022] To perform a systematic review and meta-analysis of the outcomes of physician modified endografts (PMEG) for the treatment of thoraco-abdominal (TAAA) and complex abdominal aortic aneurysms (C-AAA).

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

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. [2013] To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair.

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

Evaluation of physician-modified endografts for the treatment of thoraco-abdominal and pararenal aortic pathologies at a single institution. [2022] This study aimed to describe the outcomes of high-risk patients with symptomatic or impending ruptured pararenal aneurysm and thoraco-abdominal aortic aneurysm with comorbidities unsuitable for conventional open surgery, using physician-modified endografts (PMEGs).

7. United States 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. [2017] The objective of this study was to report midterm results of an ongoing physician-sponsored investigational device exemption pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms who are deemed unfit for open repair.