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NCT01538056 · University of Washington

Physician Modified Endovascular Grafts

(PMEG)

What this study is about

The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured experimental devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to have limited or no other options for treatment.

View original scientific description

The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured investigational devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
  • Patient is \> 18 years of age
  • Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
  • Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
  • Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following: Abdominal aortic aneurysm \>5.5 cm in diameter, Aneurysm has increased in size by 0.5 cm in last 6 months, Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
  • Patient has appropriate iliac/femoral artery anatomy for access, with or without the use of a conduit, that will allow endovascular access with the physician modified endovascular graft.
  • Patient has a suitable non-aneurysmal proximal aortic neck length of \> 2 mm inferior to the most distal renal artery ostium.
  • Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of \>15 mm. The resultant repair should preserve patency in at least one hypogastric artery.
  • Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
  • Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
  • Patient has juxtarenal aortic neck angulation \< 60º
  • Patient must be willing to comply with all required follow-up exams

Exclusion criteria

  • Patients that meet ANY of the following are not eligible for enrollment into the study:
  • Patient has a mycotic aneurysm or has an active systemic infection
  • Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
  • Patient has a major surgical or interventional procedure planned within +/- 30 days of the AAA repair.
  • Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
  • Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
  • Patient has a known allergy or intolerance stainless steel or gold
  • Patient has a body habitus that would inhibit X-ray visualization of the aorta
  • Patient has a limited life expectancy of less than 1 year
  • Patient is currently participating in another investigational device or drug clinical trial
  • Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
  • Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

Where

  • Seattle, Washington

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations

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1 of 500 participants interested
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See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

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RECRUITING

Seattle

Washington

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

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Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Abdominal Aortic Aneurysms Treatment in Seattle?

Join others in Washington exploring innovative treatment options through clinical research

Abdominal Aortic Aneurysms Treatment Options in Seattle, Washington

If you're searching for Abdominal Aortic Aneurysms treatment in Seattle, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Seattle and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Abdominal Aortic Aneurysms. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Washington
Now Enrolling
Up to 500 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Abdominal Aortic Aneurysms?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Abdominal Aortic Aneurysms

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Abdominal Aortic Aneurysms Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT01538056. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.