Aortic-Stent-Register

June 20, 2016 updated by: Stiftung Institut fuer Herzinfarktforschung

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:

Study Overview

Status

Completed

Conditions

Detailed Description

  1. Endovascular Aorta-Stent-Graft

  2. 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 Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany, 79189
        • Herz-Zentrum Bad Krozingen
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik GmbH
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken Gmbh
      • Essen, Germany, 45123
        • Westdeutsches Herzzentrum Essen, Uniklinikum
      • Ludwigshafen, Germany, 67063
        • Klinikum Ludwigshafen
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg
      • München, Germany, 81737
        • Städt. Klinikum München GmbH
      • Rostock, Germany, 18057
        • Universitätsklinikum Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients being treated in one of the participating hospitals because of a disease of the distal thoracal aorta

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Missing signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
◦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
Hospital-stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Investigators

  • Study Chair: Raimund Erbel, MD, Westdeutsches Herzzentrum Essen
  • Study Chair: Holger Eggebrecht, MD, Westdeutsches Herzzentrum Essen
  • Study Chair: Thomas Helmberger, MD, Klinikum Bogenhausen
  • Study Chair: Christoph Nienaber, MD, Universitätsklinikum Rostock
  • Study Chair: Hüseyin Ince, MD, Universitätsklinikum Rostock
  • Study Chair: Harald Mudra, MD, Klinikum Neuperlach
  • Study Chair: Ralf Zahn, MD, Klinikum Ludwigshafen
  • Study Chair: Jochen Senges, MD, Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aortenstent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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