Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.

Recruiting

• Conditions: Ascending Aorta Aneurysm; Dilation of the Ascending Aorta
• Interventions: Other: aortic prosthetics

• Registration Number: NCT04372563
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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

Study Timeline

• Study Start: 2020-01-24
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-01-24
• Study Completion: 2026-01-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

1. Age less 45 years
2. Age more 75 years
3. Multiple organ failure
4. oncological disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
death	30 day after operation	death
aorto-associated complications	30 day	rupture, dissection

Secondary Outcome Measures

Name	Time	Method
increasing the diameter of the ascending aorta	1 year	increasing the diameter of the ascending aorta more than 55 mm

Trial Locations

Locations (2)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences; 🇷🇺 Tomsk, Russian Federation

Tomsk National Research Medical Center of the Russian Academy of Sciences; 🇷🇺 Tomsk, Russian Federation