nexus™ aortic arch stent graft system first in man study

Conditions: Thoracic Aortic Arch Disease; Thoracic Aortic Aneurysm

Summary: a multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by endospan ltd. patients will be followed-up for five years.

the purpose of the study is to evaluate the safety and performance of the nexus™ aortic arch stent graft system for the endovascular treatment of thoracic aortic pathologies requiring landing in the aortic arch (zone 0, zone 1, zone 2). the nexus™ aortic arch stent graft system is indicated for the endovascular treatment of thoracic aortic pathologies involving the aortic arch (such as aneurisms and dissections). the nexus™ is intended to exclude the lesion from the blood circulation in patients diagnosed with thoracic aortic pathology and who have appropriate anatomy to accommodate the nexus™ system in an endovascular procedure. the primary objectives of the study are to evaluate the safety and performance of the nexus™ aortic arch aneurysm stent graft system.

Eligibility criteria:
inclusion criteria: * male and female age ≥ 18. * any thoracic aorta pathology requiring landing in the aortic arch (zone 0, zone 1, zone2), e.g. aneurysm, dissection, false/pseudo aneurysm. * in patient with a thoracic aneurysm: dilatation of the aortic arch larger than 5.5cm in diameter, or symptomatic aneurysm of the aortic arch, or aortic diameter growth rate \> 5mm per 6 months * patient is considered an appropriate candidate for an elective surgery, as evaluated by physical status classification system i, ii or iii (american society of anesthesiologists). * femoral artery diameter as documented by cta or mra that allows endovascular access to the diseased site with a 20-22fr delivery catheter. * access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by cta, mra. * access vessel (femoral/iliac) diameter \> 7 mm * ascending aorta landing zone length \> 30 mm * brachial/axial artery diameter \> 3 mm * patient understands and is voluntarily willing to participate as evidenced by personally signing the informed consent document, and willingness to comply with follow-up schedule exclusion criteria: * female is of childbearing potential * life expectancy of less than 1 year * any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure. * acutely ruptured or instable aneurysm or an acute vascular injury due to trauma or infected penetrating ulcers of the aorta. * patient with an increased risk for aneurysm rupture during the procedure. * patient whose arterial access site is not anticipated to accommodate the access of the nexus™ delivery system, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture) * patients with severe atherosclerosis or intraluminal thrombus of the aorta or in the bct * patient is suffering from unstable angina or nyha classification iii and iv and/or asa classification iv and above. * patient has had a myocardial infarction (mi) or cerebral vascular accident (cva) within 3 months prior to the planned implantation * patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment. * patient with a contraindication to undergo angiography * patient with known sensitivities or allergies to the device materials- nitinol and polyester * clinical conditions that severely inhibit x-ray visualization of the aorta. * connective tissue disease (e.g., marfan's or ehler's-danlos syndromes) * patient has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator * patient has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture and/or leukocytosis (wbc \> 11,000 mm3). * patients who have the condition that threatens to infect the stent graft. * acute renal failure; chronic renal failure (excluding dialysis); creatinine \> 2.00 mg/dl or \> 182 umol/l * patient underwent major surgery or interventional procedure in the last three months. * any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment. * active participation in another clinical trial that is reasonable to conflict with the nexustm study.

Keywords: taa