Aortic-Stent-Register

Aortic Dissection Clinical Trial

Official title:

Aortenstent-Register Thorakale Aorta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197651
• Other study ID #: Aortenstent
• Status: Completed
• Phase: N/A
• First received: September 7, 2010
• Last updated: June 20, 2016
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: June 2016
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Dissection

Locations

Country	Name	City	State
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Westdeutsches Herzzentrum Essen, Uniklinikum	Essen
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Städt. Klinikum München GmbH	München
Germany	Universitätsklinikum Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?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		Hospital-stay	No