Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
Investigational Device The Horizonâ„¢ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System.
Purpose The purpose of the study is to evaluate the safety and performance of the Horizonâ„¢ AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac aneurysms. The results of this study will be used as supportive data for CE Marking submission in the European Union (EU).
Objectives The primary objectives of the study are to evaluate the safety and performance of the Horizonâ„¢ AAA Stent graft System.
Primary End Points Safety endpoints include proportion of patients free from device related Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance endpoints include successful delivery and deployment of the device; and absence of the following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration.
Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular access techniques and devices.
Treatment All patients will be treated by implantation of the Horizonâ„¢ Abdominal Aortic Aneurysm Stent graft System.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female age ≥ 18.
✓. Presence of at least one of the following:
✓. 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 of ≥6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter.
✓. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA.
✓. To be eligible to receive the Horizon having the following characteristics, as demonstrated on CTA or MRA imaging:
Exclusion criteria
✕. If female and of childbearing potential , patients who are:
✕. pregnant (as determined by a positive pregnancy test performed between 10 to 5 days before implantation date), or
. intend to become pregnant during the study period, or
✕. do not accept to use adequate double barrier contraception methods for the entire study duration to avoid pregnancy
✕. 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.
✕. Patient is in need for an emergent surgery for a ruptured aneurysm.
✕. Patient with an increased risk for aneurysm rupture, such as, saccular aneurysm, aneurysm with isolated wall protrusion and penetrating ulcers of the aorta.