Clinical trial NCT01197651: Aortic-Stent-Register
Official title: Aortenstent-Register Thorakale Aorta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Keywords: Aorta
Aorta-Stent-Graft
Surgical operation
Aortic dissection
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 199
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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:

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 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

Primary outcomes:
measure: ◦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
timeFrame: Hospital-stay
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum Essen, Uniklinikum
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: München
country: Germany
facility: Städt. Klinikum München GmbH
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock
Study officials:
affiliation: Westdeutsches Herzzentrum Essen
name: Raimund Erbel, MD
role: STUDY_CHAIR
affiliation: Westdeutsches Herzzentrum Essen
name: Holger Eggebrecht, MD
role: STUDY_CHAIR
affiliation: Klinikum Bogenhausen
name: Thomas Helmberger, MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Rostock
name: Christoph Nienaber, MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Rostock
name: Hüseyin Ince, MD
role: STUDY_CHAIR
affiliation: Klinikum Neuperlach
name: Harald Mudra, MD
role: STUDY_CHAIR
affiliation: Klinikum Ludwigshafen
name: Ralf Zahn, MD
role: STUDY_CHAIR
affiliation: Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg
name: Jochen Senges, MD
role: STUDY_CHAIR
References: