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Aortic-Stent-Register

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197651
First received: September 7, 2010
Last updated: June 20, 2016
Last verified: June 2016
  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:


Condition
Aortic Dissection

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

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • ◦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 ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: October 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Bad Krozingen, Germany, 79189
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Westdeutsches Herzzentrum Essen, Uniklinikum
Essen, Germany, 45123
Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063
Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Städt. Klinikum München GmbH
München, Germany, 81737
Universitätsklinikum Rostock
Rostock, Germany, 18057
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

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01197651     History of Changes
Other Study ID Numbers: Aortenstent 
Study First Received: September 7, 2010
Last Updated: June 20, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 26, 2016