Aortic-Stent-Register

NCT ID: NCT01197651

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raimund Erbel, MD

Role: STUDY_CHAIR

Westdeutsches Herzzentrum Essen

Holger Eggebrecht, MD

Role: STUDY_CHAIR

Westdeutsches Herzzentrum Essen

Thomas Helmberger, MD

Role: STUDY_CHAIR

Klinikum Bogenhausen

Christoph Nienaber, MD

Role: STUDY_CHAIR

Universitätsklinikum Rostock

Hüseyin Ince, MD

Role: STUDY_CHAIR

Universitätsklinikum Rostock

Harald Mudra, MD

Role: STUDY_CHAIR

Klinikum Neuperlach

Ralf Zahn, MD

Role: STUDY_CHAIR

Klinikum Ludwigshafen

Jochen Senges, MD

Role: STUDY_CHAIR

Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Herz-Zentrum Bad Krozingen

Bad Krozingen, , Germany

Site Status

Kerckhoff-Klinik GmbH

Bad Nauheim, , Germany

Site Status

Segeberger Kliniken GmbH

Bad Segeberg, , Germany

Site Status

Westdeutsches Herzzentrum Essen, Uniklinikum

Essen, , Germany

Site Status

Klinikum Ludwigshafen

Ludwigshafen, , Germany

Site Status

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Site Status

Städt. Klinikum München GmbH

München, , Germany

Site Status

Universitätsklinikum Rostock

Rostock, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Aortenstent

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SOURCE XT REGISTRY
NCT01238497 COMPLETED
Sentinel Low Risk Registry
NCT04131127 COMPLETED