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

Primary Purpose

Ascending Aorta Aneurism, Aortic Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Aortic valve reimplantation using Valsalva prosthesis
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascending Aorta Aneurism focused on measuring Ascending aorta aneurism, Aortic insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dmitry A. Sirota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valsalva

Arm Description

Reimplantation procedure using Valsalva prosthesis

Outcomes

Primary Outcome Measures

all causes of aortic valve replacement
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed

Secondary Outcome Measures

all causes of death after procedure
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed

Full Information

First Posted
September 27, 2011
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01456975
Brief Title
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
Acronym
EPSTAAA
Official Title
Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascending Aorta Aneurism, Aortic Insufficiency
Keywords
Ascending aorta aneurism, Aortic insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Valsalva
Arm Type
Experimental
Arm Description
Reimplantation procedure using Valsalva prosthesis
Intervention Type
Procedure
Intervention Name(s)
Aortic valve reimplantation using Valsalva prosthesis
Other Intervention Name(s)
Gelweave Vascutek Valsalva
Intervention Description
Aortic valve reimplantation (David procedure)using Valsalva prosthesis
Primary Outcome Measure Information:
Title
all causes of aortic valve replacement
Description
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Time Frame
before discharging (average of 2 weeks after surgery)
Secondary Outcome Measure Information:
Title
all causes of death after procedure
Description
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Time Frame
6, 12, 24,36,48,60,72, 84, 96 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dmitry A. Sirota
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

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Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism

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