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

January 5, 2024 updated by: St. Olavs Hospital
The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patient treated at St. Olavs Hospital in the period January 2017 until December 2019 with endovascular aortic repair using the Zenith Alpha Spiral-Z® .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-36 months
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
12-36 months
Percentage of patients who died post-surgery
Time Frame: 12-36 months
Death of any cause during the observation time
12-36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Investigators

  • Study Director: Morten Troøyen, md, St Olavs Hospital, Dept Radiology and Nuclear Medicine
  • Study Director: Birger H Endreseth, md, St Olavs Hospital, Dept Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137828

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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