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

Aorta Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564560
• Other study ID #: 137828
• Status: Completed
• Start date: September 22, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2024
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• 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

Related Conditions & MeSH terms

• Aneurysm
• Aorta Aneurysm
• Aortic Aneurysm
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Norway	St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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