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

Completed

• Conditions: Aorta Aneurysm
• Interventions: Procedure: Endovascular aortic repair with Zenith Alpha Spiral-Z®

• Registration Number: NCT04564560
• Lead Sponsor: St. Olavs Hospital

Brief 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.

Study Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with Zenith Alpha Spiral-Z®	Endovascular aortic repair 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

Primary Outcome Measures

Name	Time	Method
Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg	12-36 months	Any amputation in the affected limb / same side as thrombosed stent graft leg
Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg	12-36 months	Any endovascular or surgical procedure to treat thrombosis or occlusion
Percentage of patients who died post-surgery	12-36 months	Death of any cause during the observation time

Trial Locations

Locations (1)

St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine; 🇳🇴 Trondheim, Norway