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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04564560

Enrollment

161

Registered

2020-09-25

Start date

2020-09-22

Completion date

2022-12-31

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aorta Aneurysm

Keywords

Stents, Thrombosis

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.

Interventions

PROCEDUREEndovascular 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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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 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 died post-surgery	12-36 months	Death of any cause during the observation time

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026