Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-22

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.

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Detailed Description

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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.

Conditions

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Aorta Aneurysm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Endovascular aortic repair with Zenith Alpha Spiral-Z®

Intervention Type 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

Interventions

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Endovascular aortic repair with Zenith Alpha Spiral-Z®

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

Intervention Type PROCEDURE

Eligibility Criteria

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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