Aorta Aneurysm Clinical Trial
Official title:
Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®
NCT number | NCT04564560 |
Other study ID # | 137828 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 22, 2020 |
Est. completion date | December 31, 2022 |
Verified date | January 2024 |
Source | St. Olavs Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.
Status | Completed |
Enrollment | 161 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients that have received endovascular treatment with the Zenith Alpha Spiral-Z® for an aortic aneurysm - The endovascular procedure was performed at St Olavs Hospital from January 2017 until December 2019 Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Norway | St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine | Trondheim |
Lead Sponsor | Collaborator |
---|---|
St. Olavs Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Percentage of patients who died post-surgery | Death of any cause during the observation time | 12-36 months |
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