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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with Zenith Alpha Spiral-Z® | Patients that from January 2017 until December 2019 received endovascular aortic repair with the Zenith Alpha Spiral-Z® at St. Olavs Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular aortic repair with Zenith Alpha Spiral-Z® | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12-36 months |
| Percentage of patients who died post-surgery | Death of any cause during the observation time | 12-36 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patient treated at St. Olavs Hospital in the period January 2017 until December 2019 with endovascular aortic repair using the Zenith Alpha Spiral-Z® .
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| Name | Affiliation | Role |
|---|---|---|
| Morten Troøyen, md | St Olavs Hospital, Dept Radiology and Nuclear Medicine | Study Director |
| Birger H Endreseth, md | St Olavs Hospital, Dept Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine | Trondheim | Norway |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| D016769 |
| Embolism and Thrombosis |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |