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OpenTrials
Completed

NCT Number: NCT01197651

Aortic-Stent-Register

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:

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ◦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

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Registry information

Official study title

Aortenstent-Register Thorakale Aorta

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 9, 2010
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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