Full Sternotomy vs Mini-sternotomy for Ascending Aortic Pathology
Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology
1 other identifier
interventional
200
1 country
1
Brief Summary
This study investigates outcomes after hemiarch repair in patients with chronic ascending aortic disease. The patients will be divided into two groups according to surgical approach: 100 patients will undergo hemiarch repair via full sternotomy (FS group) and 100 patients will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Early and late outcomes will be recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2022
CompletedFirst Submitted
Initial submission to the registry
December 10, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 5, 2026
January 1, 2026
5.4 years
December 10, 2025
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early mortality
The difference in the incidence of early mortality between groups (p-value).
during follow-up time - 60 months
Secondary Outcomes (11)
Delirium (percent)
Perioperative/Periprocedural
Transient ischemic attack (percent)
Perioperative/Periprocedural
Stroke (percent)
during follow-up time - 60 months
Respiratory failure (percent)
Perioperative/Periprocedural
New arrythmia (percent)
during follow-up time - 60 months
- +6 more secondary outcomes
Study Arms (2)
Full Sternotomy
ACTIVE COMPARATOR100 patients who will undergo hemiarch repair via full sternotomy
Mini J-Sternotomy
ACTIVE COMPARATOR100 patients who will undergo hemiarch repair via J-shaped mini-sternotomy
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent.
- Ascending aorta greater than 5 cm without involving the aortic arch
You may not qualify if:
- Acute aortic dissection or urgent/emergent cases.
- Redo aortic surgery.
- Aortic arch surgery.
- Concomitant CABG or left ventricle restoration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia
Tomsk, 634012, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris N. Kozlov, MD, PhD
Cardiology Research Institute, Tomsk National Research Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2025
First Posted
February 4, 2026
Study Start
July 10, 2022
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 5, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share