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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 <!-- --> 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 <!-- --> 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

Treatments Being Tested

DEVICE

Custom Made Fenestrated or Branched Stent Graft

The surgeon will place a custom made graft, t-Branch device or modify commercially available stent grafts to match the anatomy of the patient being treated. Small fenestrations (holes) will be made in the stent graft so that additional stents can be inserted through the fenestration and into the blood vessels that lead to the kidneys, intestines or liver. These stents allow blood to flow freely to these organs. If the aneurysm is in the aortic arch stents may be placed in the carotid and subclavian arteries. This surgery is done through small incisions in the groin and sometimes in the upper arm.

Locations (1)

UMass Memorial Health Care - University Campus
Worcester, Massachusetts, United States