NCT04564560

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 161 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed description

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

• Aorta Aneurysm

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-09-25
• Last updated: 2024-01-08

Locations

1 site across 1 country: Norway