Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism (EPSTAAA)

September 21, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation

Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency

The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aortic insufficiency 2+
  2. Ascending aorta size more than 5 cm
  3. Ascending aorta size more than 4,5 cm (Marfan syndrome)
  4. Good conditions of aortic cusps

Exclusion Criteria:

  1. Aortic annulus more than 30 mm
  2. Aortic cusps destruction
  3. Critical aortic cusps elongation
  4. Aortic root dissection

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Valsalva
Reimplantation procedure using Valsalva prosthesis
Procedure: Aortic valve reimplantation using Valsalva prosthesis
Aortic valve reimplantation (David procedure)using Valsalva prosthesis
Other Names:
  • Gelweave Vascutek Valsalva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all causes of aortic valve replacement
Time Frame: before discharging (average of 2 weeks after surgery)
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
before discharging (average of 2 weeks after surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all causes of death after procedure
Time Frame: 6, 12, 24,36,48,60,72, 84, 96 months after procedure
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
6, 12, 24,36,48,60,72, 84, 96 months after procedure

Collaborators and Investigators

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

Sponsor

Meshalkin Research Institute of Pathology of Circulation

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

January 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 21, 2011

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVAPRO

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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