Laser In Situ Fenestration Study

Inclusion Criteria13

• Aortic aneurysm \>5.5 cm in a man or \> 5.0 cm in a woman or rapid expansion deemed at significant risk for rupture in the juxtarenal or pararenal aorta.
• Endovascular aortic repair requiring coverage of renovisceral branches.
• Not candidate or at high risk for open repair. For example, but not exclusively, due to renal dysfunction, previous abdominal surgery, obese body habitus, previous coronary bypass grafts or high cardiac risk, chronic obstructive pulmonary disease (COPD) or on oxygen at rest, poorly controlled diabetes, current smoking, or antiplatelet or anticoagulation use.
• Proximal aortic landing zone in Zone 5 of the aorta or previous graft of at least 10 mm in length and diameter of between 20 and 40 mm.
• Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.
• At least a 5 mm iliofemoral artery to accept the endovascular stent graft device and an axillary brachial artery of sufficient diameter to accept the laser catheter.
• Renovisceral diameter between 4 and 13 mm at the origin.
• At the time of case planning, the patient's anatomy appears amenable to complete exclusion of the aneurysm with laser fenestration techniques.
• Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices.
• Not a candidate for currently approved endovascular options.
• years or older.
• Patient or legally authorized representative agrees to participate in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits.