Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Launched by ANDRES SCHANZER · Jan 28, 2014

Keywords

ClinConnect Summary

This clinical trial is studying new ways to treat complex aortic aneurysms using custom-made devices and modified grafts. These aneurysms can be challenging to repair with standard treatments, especially for patients with unique blood vessel shapes or those who are at high risk for traditional surgery. The trial is open to adults, including those with connective tissue disorders like Marfan syndrome and Ehlers-Danlos syndrome, who meet specific criteria such as having a large aneurysm (5.5 cm or more) or one that is growing quickly.

Participants in this study can expect to receive personalized care using innovative devices designed for their particular needs. They will need to commit to follow-up appointments for five years to monitor their progress. It’s important to note that not everyone will qualify; for example, patients with certain medical conditions or anatomical issues that could complicate the procedure may be excluded. This trial aims to provide safer and more effective treatment options for individuals facing complex aortic aneurysm challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * A patient may be suitable for inclusion in the study if the patient has at least one of the following:
• • 1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
• • 2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms
• • General Inclusion Criteria
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• • 1. Cannot be treated with a currently available non-modified approved device
• • 2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
• • 3. At least 18 years of age
• • 4. Not pregnant or breastfeeding
• • 5. Willing and able to comply with five years of follow-up
• • 6. Willing and able to provide informed consent prior to enrollment
• • 7. No systemic or local infection that may increase the risk of endovascular graft infection
• 8. High risk for open surgical repair based on any of the factors below:
• • a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD
• Exclusion Criteria:
• • Exclusion Criteria Medical Exclusion Criteria
• • 1. Cultural objection to receipt of blood or blood products
• • 2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
• • 3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated
• • 4. Uncorrectable coagulopathy
• • 5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
• • 6. Patient has active malignancy with life expectancy of less than 2 years
• • 7. Patient has life expectancy less than two years
• • Anatomical Exclusion Criteria
• • 1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
• • 2. Proximal neck length ≤25 mm
• • 3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)
• • 1. For use of Zenith Flex: diameter \>32 mm or \<18 mm
• • 2. For use of Zenith TX2: diameter \>38 mm or \<24 mm (for proximal and distal neck diameter)
• • 4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
• • 5. Proximal neck diameter change over the length of the proximal seal zone \>4 mm
• • 6. Proximal seal site with a circumferential thrombus/atheroma
• • 7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \<7.0 mm at any point along access length (prior to deployment)
• • 8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \>21 mm at distal fixation site
• • 9. Iliac artery distal fixation site \<10 mm in length
• • 10. Non-bifurcated segment of any artery to be stented \< 15 mm in length
• • 11. Artery to be stented with a maximum diameter \<3 mm or \>10 mm at the vessel ostium
• • 12. Inability to maintain at least one patent hypogastric artery