Study of Treatment of Thoracic Aortic Aneurysms and Dilat... | NCT04372563

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 24, 2020Actual

Primary Completion Date

Jan 24, 2025Estimated

Completion Date

Jan 24, 2026Estimated

First Submitted Date

Apr 29, 2020

First Submission Date that Met QC Criteria

Apr 29, 2020

First Posted Date

May 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2024

Last Update Posted Date

Nov 25, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Evgenia V. Lelik, researcher, Tomsk National Research Medical Center of the Russian Academy of SciencesPrincipal Investigator

Lead Sponsor

Tomsk National Research Medical Center of the Russian Academy of SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta

Detailed Description

Expanding indications for surgical treatment of patients with borderline values of the ascending aorta

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
healthy	Healthy patients with normal aortic dimensions	Other: aortic prosthetics
ascending aortic dilation 45-55, operated on	patients with ascending aortic dilation 45-55, tricuspid aortic valves operated on	Other: aortic prosthetics
ascending aortic dilation 45-55, non operated on	patients with ascending aortic dilation 45-55, tricuspid aortic valves non operated	Other: aortic prosthetics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aortic prosthetics	Other	aortic prosthetics	ascending aortic dilation 45-55, non operated on ascending aortic dilation 45-55, operated on healthy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death	death	30 day after operation
aorto-associated complications	rupture, dissection	30 day

Secondary Outcomes

Measure	Description	Time Frame
increasing the diameter of the ascending aorta	increasing the diameter of the ascending aorta more than 55 mm	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Extension of the ascending aorta less than 55 mm
Tricuspid Aortic Valves.
Extension of the ascending aorta more than 45 mm

Exclusion Criteria:

Age less 45 years
Age more 75 years
Multiple organ failure
oncological disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with computed tomography-diagnosed ascending aortic dilation greater than 45 mm, less than 55 mm with tricuspid aortic valve compared to patients with bicuspid aortic valve and healthy volunteers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Boris N Kozlov, MD	Contact	3822558122		hospital@cardio-tomsk.ru
Boris N Kozlov, MD	Contact	89069541331		eva00@list.ru

Overall Officials

Name	Affiliation	Role
Evgeniya V Lelik, PhD	Tomsk National Research Medical Center of the Russian Academy of Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences	Recruiting	Tomsk		634012	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Evgenia V. Lelik, researcher, Tomsk National Research Medical Center of the Russian Academy of Sciences

Unposted Events

Type	Date	Date Unknown
Release	Dec 15, 2025
Reset	Jan 5, 2026

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Dec 15, 2025

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D017545	Aortic Aneurysm, Thoracic
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases