Aortic Aneurysm, AbdominalNCT04935268
Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment
An observational study of Aortic Aneurysm, Abdominal, run by Ryazan State Medical University at 1 site in Germany.
Trial summary
The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches. Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2021to 1 Nov 2023
- How long will I take part?
- 60 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients wit infrarenal Aortic Aneurysms
Who may be able to join
- Infrarenal Aortic Aneurysm
Who cannot join
- Other Aneurysms
Trial locations and contacts
1 site in 1 country.
About this study
The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches.
Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical treatment.
Determination of genetic polymorphisms will reduce the number of postoperative complications by predicting of possible complications in the long term period.
- Conditions
- Aortic Aneurysm, Abdominal
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Mortality
Measured: 1-60 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 May 2021
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor A Suchkov, Prof, Study director, Ryazan State Medical UniversityEgan Kalmykov, Dr, Principal investigator, Clinic of Vascular Surgery, Frechen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935268
- Sponsor's protocol ID
- Ryazan Medical University
- Status last verified
- Aug 2022
- First submitted
- 15 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment
- ClinicalTrials.gov ID
- NCT04935268
- Acronym / sponsor ID
- Ryazan Medical University
- Conditions
- Aortic Aneurysm, Abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 22 Jun 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.
The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches.
Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical treatment.
Determination of genetic polymorphisms will reduce the number of postoperative complications by predicting of possible complications in the long term period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients wit infrarenal Aortic Aneurysms
Key inclusion criteria (1 listed)
- Infrarenal Aortic Aneurysm
Key exclusion criteria (1 listed)
- Other Aneurysms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 1-60 Month
Mortality
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 18 Nov 2023.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
Igor A Suchkov, Prof study director
Ryazan State Medical University
Egan Kalmykov, Dr principal investigator
Clinic of Vascular Surgery, Frechen
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 Aortic Aneurysm, Abdominal, run by Ryazan State Medical University at 1 site in Germany.
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 1 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 18 Nov 2023. 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 Germany. 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?
Survival (time frame: 1-60 Month). 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 18 Nov 2023.