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

Ascending Aorta Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372563
• Other study ID #: Aortic Aneurysm & Dilation
• Status: Recruiting
• Start date: January 24, 2020
• Est. completion date: January 24, 2026

Study information

• Verified date: May 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: Boris N Kozlov, MD
• Phone: 3822558122
• Email: hospital[@]cardio-tomsk.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 24, 2026
• Est. primary completion date: January 24, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Ascending Aorta Aneurysm
• Bicuspid Aortic Valve Disease
• Dilation of the Ascending Aorta

Intervention

Other:
• aortic prosthetics
aortic prosthetics

Locations

Country	Name	City	State
Russian Federation	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

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death	30 day after operation
Primary	aorto-associated complications	rupture, dissection	30 day
Secondary	increasing the diameter of the ascending aorta	increasing the diameter of the ascending aorta more than 55 mm	1 year