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Completed

NCT Number: NCT04564560

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

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

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Key information

Conditions

Aorta Aneurysm Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine

Trondheim, Norway

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular aortic repair with Zenith Alpha Spiral-Z®

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

Primary outcomes

  1. Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg

    Time frame: 12-36 months

    Any endovascular or surgical procedure to treat thrombosis or occlusion

  2. Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg

    Time frame: 12-36 months

    Any amputation in the affected limb / same side as thrombosed stent graft leg

  3. Percentage of patients who died post-surgery

    Time frame: 12-36 months

    Death of any cause during the observation time

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2020
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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