RecruitingNot ApplicableNCT02050113

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

Sponsor

Andres Schanzer

Enrollment

600 participants

Start Date

Mar 1, 2014

Study Type

INTERVENTIONAL

Conditions

Ehlers-Danlos Syndrome Complex Aortic Aneurysms Thoracoabdominal Aneurysms Pararenal Aneurysms Juxtarenal Aneurysms Marfan Syndrome Loeys-Dietz Syndrome Aortic Arch Aneurysm

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

A patient may be suitable for inclusion in the study if the patient has at least one of the following:
Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms
Cannot be treated with a currently available non-modified approved device
Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
At least 18 years of age
Not pregnant or breastfeeding
Willing and able to comply with five years of follow-up
Willing and able to provide informed consent prior to enrollment
No systemic or local infection that may increase the risk of endovascular graft infection
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 Criteria21

Cultural objection to receipt of blood or blood products
Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
Anaphylactic reaction to contrast that cannot be adequately pre-medicated
Uncorrectable coagulopathy
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 active malignancy with life expectancy of less than 2 years
Patient has life expectancy less than two years
Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
Proximal neck length ≤25 mm
Proximal neck, measured outer wall to outer wall on a sectional image (CT)
For use of Zenith Flex: diameter \>32 mm or \<18 mm
For use of Zenith TX2: diameter \>38 mm or \<24 mm (for proximal and distal neck diameter)
Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
Proximal neck diameter change over the length of the proximal seal zone \>4 mm
Proximal seal site with a circumferential thrombus/atheroma
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)
Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \>21 mm at distal fixation site
Iliac artery distal fixation site \<10 mm in length
Non-bifurcated segment of any artery to be stented \< 15 mm in length
Artery to be stented with a maximum diameter \<3 mm or \>10 mm at the vessel ostium
Inability to maintain at least one patent hypogastric artery

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Interventions

DEVICECustom 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.