STAR: Study of Aortic Root Reimplantation Procedure

• Sponsor: Meshalkin Research Institute of Pathology of Circulation (Other)
• Overall Status: Completed
• CT.gov ID: NCT01787604
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 58.6
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ascending Aortic Aneurism; Aortic Valve Insufficiency	Procedure: Aortic Root Reimplantation Procedure; Procedure: Aortic Valve Reimplantation Procedure	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 20, 2015
• Actual Study Completion Date: Nov 20, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure	Procedure: Aortic Root Reimplantation Procedure; Modified Florida Sleeve.; Other Names: Modified Florida Sleeve.
Active Comparator: Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure	Procedure: Aortic Valve Reimplantation Procedure; David I; Other Names: David I

Outcome Measures

Primary Outcome Measures

1. Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) [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..

Secondary Outcome Measures

1. Survival (Percentage, Kaplan-Meier) [up to 4 yeras]

   Estimated percentage of alive participants for 4 years after treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meshalkin State Research Institute of Circulation Pathology	Novosibirsk		Russian Federation	630055

Sponsors and Collaborators

• Meshalkin Research Institute of Pathology of Circulation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dmitry Khvan, cardiac surgeon, Meshalkin Research Institute of Pathology of Circulation
• ClinicalTrials.gov Identifier: NCT01787604
• Other Study ID Numbers: STAR
• First Posted: Feb 8, 2013
• Last Update Posted: Jun 10, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Dmitry Khvan, cardiac surgeon, Meshalkin Research Institute of Pathology of Circulation: Valve-sparing; Valve repair
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Valve Insufficiency

Study Results

Participant Flow

Arm/Group Title	Aortic Root Reimplantation Procedure	Aortic Valve Reimplantation Procedure
Arm/Group Description	Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I
Period Title: Overall Study
STARTED	32	32
COMPLETED	28	28
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Aortic Root Reimplantation Procedure	Aortic Valve Reimplantation Procedure	Total
Arm/Group Description	Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I	Total of all reporting groups
Overall Participants	32	32	64
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	59	56	58
Sex: Female, Male (Count of Participants)
Female	7 21.9%	7 21.9%	14 21.9%
Male	25 78.1%	25 78.1%	50 78.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Russia	32 100%	32 100%	64 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Root Reimplantation Procedure	Aortic Valve Reimplantation Procedure
Arm/Group Description	Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I
Measure Participants	32	32
Number [percentage of participants]	88.2 275.6%	87.7 274.1%

2. Secondary Outcome

Title	Survival (Percentage, Kaplan-Meier)
Description	Estimated percentage of alive participants for 4 years after treatment.
Time Frame	up to 4 yeras

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Root Reimplantation Procedure	Aortic Valve Reimplantation Procedure
Arm/Group Description	Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I
Measure Participants	32	32
Number [percentage of participants]	82.7 258.4%	84.6 264.4%

Adverse Events

Time Frame	up to 4 yeras
Arm/Group Title	Aortic Root Reimplantation Procedure		Aortic Valve Reimplantation Procedure
Arm/Group Description	Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.		Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I
All Cause Mortality
	Aortic Root Reimplantation Procedure		Aortic Valve Reimplantation Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/32 (12.5%)		4/32 (12.5%)
Serious Adverse Events
	Aortic Root Reimplantation Procedure		Aortic Valve Reimplantation Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Aortic Root Reimplantation Procedure		Aortic Valve Reimplantation Procedure
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.