Comparison of stAndard and Hybrid Surgical Techniques in the Treatment of proximaL Aortic dissEctions (CASTLE)

October 15, 2018 updated by: Alexander Edemskiy, Novosibirsk Scientific Research Institute for Circulatory Pathology

Comparison of Standard and Hybrid Techniques in Surgical Treatment of Proximal Aortic Dissection

The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with proximal aortic dissection operated using one of the techniques

Description

Inclusion Criteria:

  • aortic dissection type A

Exclusion Criteria:

  • age limits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Frozen elephant trunk surgery
Procedure: aortic prosthesis
ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis
Standart surgery
Procedure: aortic prosthesis
ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aorto-related events
Time Frame: 3 years
Death, reoperations,thoracoabdomminal aneurysms
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novosibirsk Scientific Research Institute for Circulatory Pathology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASTLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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