Study of Aortic Root Reimplantation Procedure (STAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01787604|
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ascending Aortic Aneurism Aortic Valve Insufficiency||Procedure: Aortic Root Reimplantation Procedure Procedure: Aortic Valve Reimplantation Procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure|
|Actual Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 20, 2015|
|Actual Study Completion Date :||November 20, 2015|
Active Comparator: Aortic Root Reimplantation Procedure
Aortic Root Reimplantation Procedure
Procedure: Aortic Root Reimplantation Procedure
Modified Florida Sleeve.
Other Name: Modified Florida Sleeve.
Active Comparator: Aortic Valve Reimplantation Procedure
Aortic Valve Reimplantation Procedure
Procedure: Aortic Valve Reimplantation Procedure
Other Name: David I
- Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) [ Time Frame: up to 4 yeras ]Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..
- Survival (Percentage, Kaplan-Meier) [ Time Frame: up to 4 yeras ]Estimated percentage of alive participants for 4 years after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787604
|Meshalkin State Research Institute of Circulation Pathology|
|Novosibirsk, Russian Federation, 630055|