Aortic DissectionNCT01197651
Aortic-Stent-Register
An observational study of Aortic Dissection, run by Stiftung Institut fuer Herzinfarktforschung at 8 sites in Germany.
Trial summary
The aims of the aorta-stent-Registry are: participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies: Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Dissection
- How many people
- 199 participants
- Where
- 8 sitesGermany
- Study dates
- Oct 2008to Oct 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients being treated in one of the participating hospitals because of a disease of the distal thoracal aorta
Who may be able to join
- Patients with significant illness of the distal thoracal aorta (distal Aortic-dissection; TAA; penetrated ulcer; covered perforation; traumatically transection of the distal thoracal aorta) including those that receive an endovascular stent or an open surgical operation.
Who cannot join
- Missing signed informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Segeberger Kliniken GmbH
Bad Segeberg, 23795
Westdeutsches Herzzentrum Essen, Uniklinikum
Essen, 45123
Klinikum Ludwigshafen
Ludwigshafen, 67063
Universitätsklinikum Magdeburg
Magdeburg, 39120
Städt. Klinikum München GmbH
München, 81737
Universitätsklinikum Rostock
Rostock, 18057
About this study
Official title: Aortenstent-Register Thorakale Aorta
The aims of the aorta-stent-Registry are:
- participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:
Read the detailed description
- Endovascular Aorta-Stent-Graft
- Surgical operation of the distal thoracal aorta
- Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine.
- Documentation of the operational risk (Euroscore)
- Documentation of the technical enforcement of the procedure as well as the result of the intervention
- Documentation of the hospital lethality and the non-fatal serious complications (Spinal Cord Ischemia, SCI, Stroke, TIA, high blood loss etc.)
- Documentation of medication at hospital discharge
- Documentation of long-term lethality and non-fatal serious complications (SCI, Stroke, TIA, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 \& 5 years.
- Conditions
- Aortic Dissection
- Keywords
- Aorta, Aorta-Stent-Graft, Surgical operation, Aortic dissection
- Medical subject headings
- Aortic Dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
◦Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine
Measured: Hospital-stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startOct 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies 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
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raimund Erbel, MD, Study chair, Westdeutsches Herzzentrum EssenHolger Eggebrecht, MD, Study chair, Westdeutsches Herzzentrum EssenThomas Helmberger, MD, Study chair, Klinikum BogenhausenChristoph Nienaber, MD, Study chair, Universitätsklinikum RostockHüseyin Ince, MD, Study chair, Universitätsklinikum RostockHarald Mudra, MD, Study chair, Klinikum NeuperlachRalf Zahn, MD, Study chair, Klinikum LudwigshafenJochen Senges, MD, Study chair, Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197651
- Sponsor's protocol ID
- Aortenstent
- Status last verified
- Jun 2016
- First submitted
- 7 Sep 2010
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortenstent-Register Thorakale Aorta
- ClinicalTrials.gov ID
- NCT01197651
- Acronym / sponsor ID
- Aortenstent
- Conditions
- Aortic Dissection
- Keywords
- Aorta, Aorta-Stent-Graft, Surgical operation, Aortic dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Sep 2010 (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.
The aims of the aorta-stent-Registry are:
- participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:
Detailed description
- Endovascular Aorta-Stent-Graft
- Surgical operation of the distal thoracal aorta
- Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine.
- Documentation of the operational risk (Euroscore)
- Documentation of the technical enforcement of the procedure as well as the result of the intervention
- Documentation of the hospital lethality and the non-fatal serious complications (Spinal Cord Ischemia, SCI, Stroke, TIA, high blood loss etc.)
- Documentation of medication at hospital discharge
- Documentation of long-term lethality and non-fatal serious complications (SCI, Stroke, TIA, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 \& 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients being treated in one of the participating hospitals because of a disease of the distal thoracal aorta
Key inclusion criteria (1 listed)
- Patients with significant illness of the distal thoracal aorta (distal Aortic-dissection; TAA; penetrated ulcer; covered perforation; traumatically transection of the distal thoracal aorta) including those that receive an endovascular stent or an open surgical operation.
Key exclusion criteria (1 listed)
- Missing signed informed consent
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
◦Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine
Time frame: Hospital-stay
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 21 Jun 2016.
- 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.
Raimund Erbel, MD study chair
Westdeutsches Herzzentrum Essen
Holger Eggebrecht, MD study chair
Westdeutsches Herzzentrum Essen
Thomas Helmberger, MD study chair
Klinikum Bogenhausen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Stiftung Institut fuer Herzinfarktforschung at 8 sites 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 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
◦Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine (time frame: Hospital-stay). 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 21 Jun 2016.