What side effects are associated with this type of intervention?

Common side effects of treatments for Abdominal Aortic Aneurysm (AAA), particularly endovascular aneurysm repair (EVAR) similar to the Physician-Modified Endograft, include endoleaks, device migration, stent graft kinking or fracture, and access site complications such as bleeding or infection. Open surgical repair, while more invasive, can lead to complications such as infection, bleeding, heart attack, and prolonged recovery time. Both treatments require careful monitoring for potential late complications, including graft failure and aneurysm recurrence.

What prior FDA approvals exist?

The FDA has approved several endografts for the treatment of Abdominal Aortic Aneurysm (AAA), which provide structural support to the aorta to prevent aneurysm rupture. These devices include the Gore Excluder, Medtronic Endurant, and Cook Zenith endografts. These endovascular stent-grafts are designed to reinforce the weakened section of the aorta, thereby reducing the risk of rupture. The Physician-Modified Endograft, currently under investigation, aims to treat complex aortic aneurysms by covering critical arteries such as the renal arteries, superior mesenteric artery, or celiac trunk, offering a tailored approach for high-risk patients with specific anatomical needs.

What other types of research exist?

Promising novel alternatives to Physician-Modified Endograft for AAA patients in 2024 include: 1) Custom-made fenestrated and branched endografts, which are tailored to the patient's specific anatomy and can address complex aneurysms involving visceral arteries. 2) Drug-eluting stents, which release medication to prevent restenosis and improve long-term outcomes. 3) Advanced imaging-guided endovascular techniques, such as 3D navigation and robotic-assisted procedures, which enhance precision and safety. 4) Bioengineered vascular grafts, which aim to promote tissue integration and reduce complications. These alternatives offer potential improvements in treatment success and patient outcomes.

← Back to Search

Endovascular Device

Endovascular Aneurysm Repair for Aortic Aneurysm

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.

Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.

Must not have

Patient has active malignancy with life expectancy of less than 2 years

Inability to maintain at least one patent hypogastric artery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications related to the graft such as infection or allergic reactions to its components (stainless steel, polyester etc.), problems from invasive procedures like bleeding or clotting issues, and general risks associated with endovascular surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My lower artery size is between 7 and 20 mm and not bulging.

Select...

I am older than 18 years.

Select...

My iliac or femoral arteries are suitable for a specific type of endovascular procedure.

Select...

My aorta near my heart is long enough for a safe procedure.

Select...

My aorta's upper part is the right size and not an aneurysm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I cannot keep at least one main artery in my lower abdomen open.

Select...

I cannot have surgery or procedures to open blocked vessels.

Select...

My blood vessel has a clot or plaque at the site needing a seal.

Select...

I have an aneurysm caused by an infection.

Select...

I need urgent surgery for a burst blood vessel.

Select...

I have a blood clotting disorder that cannot be corrected.

Select...

I have severe blockage or hardening in my blood vessels that could hinder procedures.

Select...

I have worsening chest pain, including at rest or at night.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary effectiveness endpoint

The Primary Safety Endpoint (Freedom from major adverse events [MAE])

Secondary study objectives

Follow-up outcomes

Technical success

The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Physician-Modified EndograftExperimental Treatment1 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).

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Abdominal Aortic Aneurysm (AAA) include endovascular aneurysm repair (EVAR) and open surgical repair. EVAR, similar to the Physician-Modified Endograft, involves placing a stent-graft within the aneurysm via a catheter inserted through the femoral artery. This stent-graft provides structural support to the weakened aortic wall, effectively excluding the aneurysm from blood flow and preventing rupture. This approach is less invasive than open surgery, which requires a large abdominal incision to directly repair the aneurysm. For AAA patients, these treatments are crucial as they significantly reduce the risk of aneurysm rupture, which can be life-threatening. The minimally invasive nature of EVAR also offers benefits such as reduced recovery time, lower perioperative morbidity, and shorter hospital stays.

Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts.