| NCT ID | NCT01538056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Abdominal Aortic Aneurysms |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2011-03 |
| Primary Completion | 2045-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2011-03 with a primary completion date of 2045-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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. 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 exams 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
Contact & Investigator
Benjamin W Starnes, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT01538056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Aortic Aneurysms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01538056 currently recruiting?
Yes, NCT01538056 is actively recruiting participants. Contact the research team at alari@uw.edu for enrollment information.
Where is the NCT01538056 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT01538056 clinical trial?
NCT01538056 is sponsored by University of Washington. The principal investigator is Benjamin W Starnes, MD at University of Washington. The trial plans to enroll 500 participants.