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Study of Aortic Root Reimplantation Procedure (STAR)

Primary Purpose

Ascending Aortic Aneurism, Aortic Valve Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Aortic Root Reimplantation Procedure
Aortic Valve Reimplantation Procedure
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 Aortic Aneurism focused on measuring Valve-sparing, Valve repair

Eligibility Criteria

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

Inclusion Criteria:

  • Aortic insufficiency 2+
  • Ascending aorta or aortic root of greater than 4.5 cm (> 4.0 cm in Marfan syndrome)
  • Good conditions of aortic cusps

Exclusion Criteria:

  • Aortic annulus more than 32 mm
  • Aortic cusps destruction
  • Critical aortic cusps elongation
  • Aortic root dissection

Sites / Locations

  • Meshalkin State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aortic Root Reimplantation Procedure

Aortic Valve Reimplantation Procedure

Arm Description

Aortic Root Reimplantation Procedure

Aortic Valve Reimplantation Procedure

Outcomes

Primary Outcome Measures

Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..

Secondary Outcome Measures

Survival (Percentage, Kaplan-Meier)
Estimated percentage of alive participants for 4 years after treatment.

Full Information

First Posted
January 30, 2013
Last Updated
March 10, 2019
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01787604
Brief Title
Study of Aortic Root Reimplantation Procedure
Acronym
STAR
Official Title
Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
November 20, 2015 (Actual)
Study Completion Date
November 20, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
Detailed Description
A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascending Aortic Aneurism, Aortic Valve Insufficiency
Keywords
Valve-sparing, Valve repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aortic Root Reimplantation Procedure
Arm Type
Active Comparator
Arm Description
Aortic Root Reimplantation Procedure
Arm Title
Aortic Valve Reimplantation Procedure
Arm Type
Active Comparator
Arm Description
Aortic Valve Reimplantation Procedure
Intervention Type
Procedure
Intervention Name(s)
Aortic Root Reimplantation Procedure
Other Intervention Name(s)
Modified Florida Sleeve.
Intervention Description
Modified Florida Sleeve.
Intervention Type
Procedure
Intervention Name(s)
Aortic Valve Reimplantation Procedure
Other Intervention Name(s)
David I
Intervention Description
David I
Primary Outcome Measure Information:
Title
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
Description
Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..
Time Frame
up to 4 yeras
Secondary Outcome Measure Information:
Title
Survival (Percentage, Kaplan-Meier)
Description
Estimated percentage of alive participants for 4 years after treatment.
Time Frame
up to 4 yeras

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aortic insufficiency 2+ Ascending aorta or aortic root of greater than 4.5 cm (> 4.0 cm in Marfan syndrome) Good conditions of aortic cusps Exclusion Criteria: Aortic annulus more than 32 mm Aortic cusps destruction Critical aortic cusps elongation Aortic root dissection
Facility Information:
Facility Name
Meshalkin State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
Citation
Alexander Chernyavskiy, Sergey Alsov, Dmitry Khvan, Dmitry Sirota. Extravalvular exoprosthetic repair of aortic root: first experience. Kardiochirurgia i Torakochirurgia Polska 2012; 9 (4): 409-414 DOI: 10.5114/kitp.2012.32675
Results Reference
result
Citation
Чернявский А. М., Хван Д. С., Альсов С. А., Сирота Д. А., Ляшенко М. М. Результаты реимплантации корня аорты в протез у пациентов с аневризмой восходящего отдела аорты и недостаточностью аортального клапана. Патология кровообращения и кардиохирургия. 2015;19(4):38-47. http://dx.doi.org/10.21688/1681-3472-2015-4-38-47
Results Reference
result

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Study of Aortic Root Reimplantation Procedure

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