Infrarenal Aortic AneurysmOBINCT01649908
Open Bifurcation Surgery Study
An observational study of Infrarenal Aortic Aneurysm, run by Alexander Hyhlik-Duerr, M. D. at 1 site in Germany.
Trial summary
Different cross clamping techniques in aortic surgery causes different cardiac stress Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infrarenal Aortic Aneurysm
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to not given
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with infrarenal aortic aneurysms
Who may be able to join
- AAA > 5cm
Who cannot join
- emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiac Function in Different Techniques in Infrarenal Aortic Surgery
Different cross clamping techniques in aortic surgery causes different cardiac stress
- Conditions
- Infrarenal Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sectional cross clamping | Not described | |
| simultaniously cross clamping | Not described | |
| EVAR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac function with echocardiography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infrarenal 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Hyhlik-Duerr, M. D.
- Sponsor type
- University, hospital or other
- Collaborators
- Vascutek Ltd.
- Responsible party
- Sponsor-investigator, Alexander Hyhlik-Duerr, M. D., Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649908
- Sponsor's protocol ID
- 501961
- Acronym
- OBI
- Status last verified
- Aug 2012
- First submitted
- 20 Jul 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Function in Different Techniques in Infrarenal Aortic Surgery
- ClinicalTrials.gov ID
- NCT01649908
- Acronym / sponsor ID
- OBI / 501961
- Conditions
- Infrarenal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexander Hyhlik-Duerr, M. D.University, hospital or other
- Collaborators
- Vascutek Ltd.
- Study start
- Jul 2012
- First posted
- 25 Jul 2012 (estimated)
- 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.
Different cross clamping techniques in aortic surgery causes different cardiac stress
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sectional cross clamping | – | – |
| simultaniously cross clamping | – | – |
| EVAR | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with infrarenal aortic aneurysms
Key inclusion criteria (1 listed)
- AAA > 5cm
Key exclusion criteria (1 listed)
- emergency cases
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
cardiac function with echocardiography
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infrarenal Aortic Aneurysm, run by Alexander Hyhlik-Duerr, M. D. 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: status not confirmed, as of the sponsor's last update on 7 Aug 2012. 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?
Results are not available in the source record.
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?
cardiac function with echocardiography (time frame: 2 years). 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 7 Aug 2012.