Physician Modified Endovascular Grafts

Launched by UNIVERSITY OF WASHINGTON · Feb 18, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a special type of treatment called physician modified endovascular grafts for patients with juxtarenal abdominal aortic aneurysms, which are bulges in the main artery in the abdomen that can be very dangerous. The goal is to find out if this method is safe and effective for patients who cannot have traditional surgery and have no other treatment options. Researchers are currently looking for participants aged 18 and older who have specific types of aneurysms that are large or have been growing. Other requirements include having certain blood vessels that can be used for access to the graft, and a willingness to attend follow-up exams.

To be eligible, participants should not have any serious infections, unstable heart conditions, or planned major surgeries within the next month. They should also not have certain medical conditions that could complicate the treatment. If you or someone you know is interested in this study, it’s important to discuss it with a healthcare provider to see if it’s a good fit and to understand what participation would involve.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
• • 1. Patient is \> 18 years of age
• • 2. 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)
• • 3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
• 4. 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
• • 5. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft.
• • 6. Patient has a suitable non-aneurysmal proximal aortic neck length of \> 2 mm inferior to the most distal renal artery ostium.
• • 7. 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.
• • 8. 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.
• • 9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
• • 10. Patient has juxtarenal aortic neck angulation \< 60º
• • 11. Patient must be willing to comply with all required follow-up exam-
• Exclusion Criteria:
• Patients that meet ANY of the following are not eligible for enrollment into the study:
• • 1. Patient has a mycotic aneurysm or has an active systemic infection
• • 2. 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)
• • 3. Patient has a major surgical or interventional procedure planned within +/- 30 days of the AAA repair.
• • 4. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
• • 5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• • 6. Patient has a known allergy or intolerance stainless steel or gold
• • 7. Patient has a body habitus that would inhibit X-ray visualization of the aorta
• • 8. Patient has a limited life expectancy of less than 1 year
• • 9. Patient is currently participating in another investigational device or drug clinical trial
• • 10. 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.
• • 11. Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site