Aorta AneurysmNCT04564560
Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®
An observational study of Aorta Aneurysm, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorta Aneurysm
- What is being tested?
- Endovascular aortic repair with Zenith Alpha Spiral-Z®
- Type of treatment
- Surgery or procedure
- How many people
- 161 participants
- Where
- 1 siteNorway
- Study dates
- 22 Sep 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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® .
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine
Trondheim
About this study
The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.
Read the 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.
- Conditions
- Aorta Aneurysm
- Being tested
- Endovascular aortic repair with Zenith Alpha Spiral-Z®
- Keywords
- Stents, Thrombosis
- Medical subject headings
- Aortic Aneurysm, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular aortic repair with Zenith Alpha Spiral-Z®Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Endovascular aortic repair with Zenith Alpha Spiral-Z® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12-36 months
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
Measured: 12-36 months
Percentage of patients who died post-surgery
Death of any cause during the observation time
Measured: 12-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start22 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta AneurysmStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morten Troøyen, md, Study director, St Olavs Hospital, Dept Radiology and Nuclear MedicineBirger H Endreseth, md, Study director, St Olavs Hospital, Dept Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564560
- Sponsor's protocol ID
- 137828
- Status last verified
- Jan 2024
- First submitted
- 22 Sep 2020
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®
- ClinicalTrials.gov ID
- NCT04564560
- Acronym / sponsor ID
- 137828
- Conditions
- Aorta Aneurysm
- Keywords
- Stents, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Zenith Alpha Spiral-Z® | – | Procedure: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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® .
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Patients treated with Zenith Alpha Spiral-Z® |
Primary outcome
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
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
Percentage of patients who died post-surgery
Time frame: 12-36 months
Death of any cause during the observation time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Troøyen, md study director
St Olavs Hospital, Dept Radiology and Nuclear Medicine
Birger H Endreseth, md study director
St Olavs Hospital, Dept Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorta Aneurysm, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg (time frame: 12-36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.