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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 02, 2014