NCT01197651

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:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

September 7, 2010

Last Update Submit

June 20, 2016

Conditions

Keywords

AortaAorta-Stent-GraftSurgical operationAortic dissection

Outcome Measures

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

    Hospital-stay

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients being treated in one of the participating hospitals because of a disease of the distal thoracal aorta

You may qualify if:

  • 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.

You may not qualify if:

  • Missing signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Westdeutsches Herzzentrum Essen, Uniklinikum

Essen, 45123, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

Location

Städt. Klinikum München GmbH

München, 81737, Germany

Location

Universitätsklinikum Rostock

Rostock, 18057, Germany

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

October 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 21, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations