AAA abdominal aortic aneurysm
Conditions
Interventions
AAA HORIZON TM Stent Graft System implantation.
Sponsors
Endospan Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male and female age >= 18. 2. Presence of at least one of the following: i. Abdominal aortic aneurysm >= 5.0cm in diameter (perpendicular to the line of flow). ii. Abdominal aortic aneurysm 4.5-5.5cm in diameter which increased in size - >= 0.5cm over 6 months or 1.0cm over one year. iii. Abdominal aortic aneurysm >50% larger than the normal aortic diameter. 3. 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). 4. Femoral artery diameter of >=6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter. 5. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA. 6. To be eligible to receive the Horizon having the following characteristics, as demonstrated on CTA or MRA imaging: I. Infrarenal aortic neck diameter of 18-28 mm II. Aortic length (lower renal artery to lowest point of aortic bifurcation) of 115-150 mm III. Iliac artery diameter of 10-19 mm IV. Proximal aortic neck length >= 15 mm V. Proximal aortic neck/ aneurysm angulation = 20mm VII. Aortic bifurcation angulation of >= 70°. 7. Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document.
Exclusion criteria
Exclusion criteria: 1. If female and of childbearing potential, patients who are: a. less than 5 years post-menopausal or did not undergo hysterectomy, oophorectomy or tubal ligation and do not agree to take all measures to avoid pregnancy during the period of the study. b. nursing. 2. Life expectancy of less than 1 year. 3. Any medical condition that, according to the investigator*s decision, might expose the patient to increased risk by the investigational device or procedure. 4. Patient is in need for an emergent surgery for a ruptured aneurysm. 5. Patient with an increased risk for aneurysm rupture during the procedure. 6. An Acutely ruptured or leaking aneurysm. 7. Acute traumatic dissection or vascular injury or penetrating ulcers of the aorta. 8. Presence of thrombus or atheroma in proximal aortic neck covering >50% of the endoluminal surface. 9. Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to 5.5 cm in diameter. 13. Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries. 14. Patient has a reversed conical neck defined as a > 4mm distal increase over a 10 mm length. 15. Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow. 16. Patient whose arterial access site is not anticipated to accommodate the 14 Fr diameter of the Horizon* Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture). 17. Patient underwent major surgery or interventional procedure in the last three months. 18. Patient is suffering from unstable angina or NYHA classification III and IV and/or ASA classification IV and above. 19. Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation. 20. Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment. 21. Contraindication to undergoing angiography. 22. Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester. 23. Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta. 24. Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes). 25. Patient has a history of bleeding diathesis or coagulopathy. 26. Active systemic infection at the time of the index procedure documented by either one of the following: pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3). 27. Acute renal failure documented by either one of the following: Creatinine > 2.00 mg/dl or > 182 umol/L; patient on dialysis. 28. 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. 29. Active participation in another research study involving an investigational device or new drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoint includes a proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC). MAE is defined as: all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia and procedural blood loss >= 1000ml. Performance endpoints will assess the rate of successful aneurysm treatment at 1 month, defined as: - Successful delivery and deployment of the device. - Absence of the following, as determined by an independent core-lab: aneurysm growth >=5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and clinically significant stent graft migration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients free from MAEs at 1 month through 5 years post implantation. All-cause mortality and aneurysm-related mortality through 1 and 12 months, Kaplan-Meier survival analysis. Absence of all of the following at 1 year: aneurysm growth >=5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration. Clinical utility outcomes: • Procedure duration • Fluoroscopy time and contrast medium volume • Estimated blood loss & requirement for blood transfusion • Time spent in the intensive care unit (ICU) • Length of hospital stay extending from index procedure to discharge | — |
Countries
Netherlands
Outcome results
None listed