Abdominal Aortic AneurysmNCT05172830
Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System
An observational study of Abdominal Aortic Aneurysm, run by Larissa University Hospital at 1 site in Greece.
Trial summary
This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Ovation Alto™ Abdominal Stent Graft System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2021to Dec 2022
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated electively with Ovation Alto™ Abdominal Stent Graft System for Endovascular Aneurysm Repair
Who may be able to join
- Subject is > 18 years of age
- Both IFU and non-adherence to IFU
- Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System
- Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan
Who cannot join
- Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
- Life expectancy less than 1 year
- Pregnancy
- Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Larisssa
Larissa, 41110
Konstantinos Spanos, PhD, 00306948570321, spanos.kon@gmail.com
Athanasios Giannoukas, Prof, 00306944724146, agiannoukas@gmail.com
About this study
Official title: Hellenic Registry of Subjects Receiving the Ovation Alto™ Abdominal Stent Graft System
This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Ovation Alto™ Abdominal Stent Graft System
- Keywords
- EVAR, Endovascular aneurysm repair, Ovation Alto
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovation Alto™ Abdominal Stent Graft SystemDevice
Single occurrence permanent implantation of AAA device
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort | Ovation Alto™ Abdominal Stent Graft System Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. Receives: Device: Ovation Alto™ Abdominal Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration > 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement >5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.
Measured: 12 months
Secondary outcomes (10)
Number and Classification of Endoleaks
Endoleak type Ia and Ib and III
Measured: 1 and 12 months
Stent Graft Migration
Any proximal caudal Stent Graft Migration >10mm
Measured: 1 and 12 months
Abdominal aortic aneurysm sac enlargement
Any sac enlargement > 5mm
Measured: 1 and 12 months
Aortic neck alteration
Any neck diameter increase at supra-renal part of the aorta (at 0mm, 10mm and 20mm above the highest renal artery), and infra-renal part of the aorta (at 0mm, 7mm, and 15mm below the lowest renal artery). Measurements of the aortic neck angulation will also be included
Measured: 1 and 12 months
Freedom from abdominal aortic aneurysm rupture
Recording of any abdominal aortic aneurysm rupture that takes place during the follow up after the procedure in order to assess freedom from this adverse event
Measured: 1 and 12 months
Number of Secondary Interventions
Any secondary intervention stent-graft related including: proximal extension with a balloon expandable covered stent; stent graft extension distally to common iliac arteries; use of onyx for Endoleak Ia; bare metal stent in external iliac arteries
Measured: 1 and 12 months
AAA-related mortality
Any aneurysm related mortality
Measured: 1 and 12 months
Device-related Adverse Events (AEs)
Device-related Adverse Events: loss of latency, stent fracture, migration, Endoleak type I and III
Measured: 1 and 12 months
Major adverse events
Including death, myocardial infarction, stroke, chronic renal disease, stent graft infection, amputation
Measured: 1 and 12 months
Adherence to instruction for use
Recording of patients in terms of adherence to instructions for use according to the device manual
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Patras, University Hospital of Crete, University Hospital, Alexandroupolis
- Responsible party
- Principal investigator, Konstantinos Spanos, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172830
- Sponsor's protocol ID
- 986152150
- Status last verified
- Dec 2021
- First submitted
- 15 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hellenic Registry of Subjects Receiving the Ovation Alto™ Abdominal Stent Graft System
- ClinicalTrials.gov ID
- NCT05172830
- Acronym / sponsor ID
- 986152150
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- EVAR, Endovascular aneurysm repair, Ovation Alto
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Patras, University Hospital of Crete, University Hospital, Alexandroupolis
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Dec 2021 (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.
This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort | – | Device: Ovation Alto™ Abdominal Stent Graft SystemOvation Alto™ Abdominal Stent Graft System Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated electively with Ovation Alto™ Abdominal Stent Graft System for Endovascular Aneurysm Repair
Key inclusion criteria (4 listed)
- Subject is > 18 years of age
- Both IFU and non-adherence to IFU
- Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System
- Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan
Key exclusion criteria (4 listed)
- Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
- Life expectancy less than 1 year
- Pregnancy
- Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
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 |
|---|---|---|
| Ovation Alto™ Abdominal Stent Graft SystemSingle occurrence permanent implantation of AAA device | Device | Group/Cohort |
Primary outcome
Treatment success
Time frame: 12 months
Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration > 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement >5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.
10 secondary outcomes
Number and Classification of Endoleaks
Time frame: 1 and 12 months
Stent Graft Migration
Time frame: 1 and 12 months
Abdominal aortic aneurysm sac enlargement
Time frame: 1 and 12 months
Aortic neck alteration
Time frame: 1 and 12 months
Freedom from abdominal aortic aneurysm rupture
Time frame: 1 and 12 months
Number of Secondary Interventions
Time frame: 1 and 12 months
AAA-related mortality
Time frame: 1 and 12 months
Device-related Adverse Events (AEs)
Time frame: 1 and 12 months
Major adverse events
Time frame: 1 and 12 months
Adherence to instruction for use
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
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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.
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 Abdominal Aortic Aneurysm, run by Larissa University Hospital at 1 site in Greece.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Spanos, PhD (00306948570321, spanos.kon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 12 months). 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 29 Dec 2021.