Aortic-Stent-Register

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197651
First received: September 7, 2010
Last updated: June 9, 2011
Last verified: May 2011
  Purpose

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:

    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.

Condition
Disease of the Distal Thoracal Aorta, Treated by Endovascular Aorta-Stent-Graft, or Surgical Operation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aortenstent-Register

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Estimated Enrollment: 200
Study Start Date: October 2008
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197651

Locations
Germany
Herz-Zentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Franz-Josef Neumann, MD       franz-josef.neumann@herzzentrum.de   
Kerckhoff-Klinik GmbH Recruiting
Bad Nauheim, Germany, 61231
Contact: Christian Hamm, MD       c.hamm@kerckhoff-klinik.de   
Segeberger Kliniken GmbH Recruiting
Bad Segeberg, Germany, 23795
Contact: Gert Richardt, MD       gert.richardt@segebergerkliniken.de   
Westdeutsches Herzzentrum Essen, Uniklinikum Recruiting
Essen, Germany, 45123
Contact: Raimund Erbel, MD       erbel@uk-essen.de   
Klinikum Ludwigshafen Recruiting
Ludwigshafen, Germany, 67063
Contact: Ralf Zahn, MD       zahnr@klilu.de   
Universitätsklinikum Magdeburg Recruiting
Magdeburg, Germany, 39120
Contact: Rüdiger Braun-Dullaeus, MD       r.braun-dullaeus@med.ovgu.de   
Städt. Klinikum München GmbH Recruiting
München, Germany, 81737
Contact: Harald Mudra, MD       h.mudra@kh-neuperlach.de   
Universitätsklinikum Rostock Recruiting
Rostock, Germany, 18057
Contact: Chritoph Nienaber, MD       christoph.nienaber@med.uni-rostock.de   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Prof Jochen Senges, Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01197651     History of Changes
Other Study ID Numbers: Aortenstent
Study First Received: September 7, 2010
Last Updated: June 9, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Aorta
Aorta-Stent-Graft
Surgical operation
Aortic dissection

ClinicalTrials.gov processed this record on April 17, 2014