Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: NEXUS™ Aortic Arch Stent Graft System First In Man Study

Summary: A multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.

Detailed description: 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: 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.

Relevance to patient case: not relevant