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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT01456975

First received: September 27, 2011

Last updated: November 21, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 27, 2011
Last Updated Date	November 21, 2012
Start Date ^ICMJE	January 2007
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 19, 2011)	all causes of aortic valve replacement [ Time Frame: before discharging (average of 2 weeks after surgery) ] [ Designated as safety issue: Yes ] Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01456975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 19, 2011)	all causes of death after procedure [ Time Frame: 6, 12, 24,36,48,60,72, 84, 96 months after procedure ] [ Designated as safety issue: Yes ] Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
Official Title ^ICMJE	Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Ascending Aorta Aneurism Aortic Insufficiency
Intervention ^ICMJE	Procedure: Aortic valve reimplantation using Valsalva prosthesis Aortic valve reimplantation (David procedure)using Valsalva prosthesis Other Name: Gelweave Vascutek Valsalva
Study Arm (s)	Experimental: Valsalva Reimplantation procedure using Valsalva prosthesis Intervention: Procedure: Aortic valve reimplantation using Valsalva prosthesis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	January 2017
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Aortic insufficiency 2+ Ascending aorta size more than 5 cm Ascending aorta size more than 4,5 cm (Marfan syndrome) Good conditions of aortic cusps Exclusion Criteria: Aortic annulus more than 30 mm Aortic cusps destruction Critical aortic cusps elongation Aortic root dissection
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Russian Federation

Administrative Information
NCT Number ^ICMJE	NCT01456975
Other Study ID Numbers ^ICMJE	EVAPRO
Has Data Monitoring Committee	No
Responsible Party	Meshalkin Research Institute of Pathology of Circulation
Study Sponsor ^ICMJE	Meshalkin Research Institute of Pathology of Circulation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Meshalkin Research Institute of Pathology of Circulation
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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