The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.
Cook Medical has reported thrombus formation with or without occlusion of the Zenith Alpha Spiral-Z®. The purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at St. Olavs Hospital in 2017, 2018 and 2019. Information is collected from the Norwegian registry for vascular surgery (NORKAR), electronic patient journal and the picture archiving and communication system (PACS). The total number of included patients is estimated to be approximately 100.
Study Type
OBSERVATIONAL
Enrollment
161
The Zenith Alpha Spiral-Z® stent graft may have an increased risk of thrombosis. The intervention in this study is to assess the extent and degree of thrombosis in patients treated with the Zenith Alpha Spiral-Z® during endovascular repair of aortic aneurysm
St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine
Trondheim, Norway
Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg
Any endovascular or surgical procedure to treat thrombosis or occlusion
Time frame: 12-36 months
Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg
Any amputation in the affected limb / same side as thrombosed stent graft leg
Time frame: 12-36 months
Percentage of patients who died post-surgery
Death of any cause during the observation time
Time frame: 12-36 months
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