Ascending Aortic AneurysmNCT07386028
Full Sternotomy vs Mini-sternotomy for Ascending Aortic Pathology
A study testing Full sternotomy and J-shaped mini-sternotomy in people with Ascending Aortic Aneurysm, run by Tomsk Cardiology Research Institute at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ascending Aortic Aneurysm
- What is being tested?
- Full sternotomy and J-shaped mini-sternotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jul 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Ascending aorta greater than 5 cm without involving the aortic arch
Who cannot join
- Acute aortic dissection or urgent/emergent cases.
- Redo aortic surgery.
- Aortic arch surgery.
- Concomitant CABG or left ventricle restoration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia
Tomsk, 634012
Dmitri S. Panfilov, MD, PhD, +79039130879, pand2006@yandex.ru
About this study
Official title: Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology
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.
Read the detailed description
- Relevance of the study Hemiarch repair is an effective treatment for patients with ascending aortic aneurysm (AAR). All aortic procedures are routinely performed from full mean sternotomy but nowadays this standard could be performed via minimally invasive approach as well. There are some data that mini-J sternotomy is associated with less blood loss and blood products transfusion, improved lung function and eliminates wound complications risks. The aim of this study was to assess the morbidity and mortality after hemiarch repair via full or J-shaped mini-sternotomy.
- Patients and methods Patients who will undergo hemiarch repair procedure via full sternotomy (FS group) will be compared with patients who will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Baseline characteristics including preoperative clinical status, details on surgery, and postoperative outcomes will be compared between these groups. Follow-up data will be recorded.
Imaging All aortic measurements will be assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta will be performed within 2 weeks after surgery. Analysis will be performed using 64-slice scanner Discovery NM-CT 570c (GE Healthcare, Milwaukee, WI, USA) with spatial resolution of the angiographic phase ranging from 0.6 to 1.25 mm. All measurements will be taken always in the plane perpendicular to the manually corrected local aortic centre line. Ascending aortic diameter will be measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm) will be measured from the outer contours of the aortic wall. All images will be independently assessed by two experienced cardiologists.
Surgical technique The hemiarch repair is performed via a full sternotomy or J-shaped mini-sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion through the innominate artery with side graft. The distal aortic anastomosis is performed using an open anastomosis fashion and involved resection of the inferior portion of the aortic arch from the base of the innominate artery to the projection of the origin of the left subclavian artery. Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) is used for cerebral monitoring during the operation. When the target temperature is achieved, lower body circulatory arrest with antegrade cerebral perfusion is initiated. The distal aortic anastomosis is performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic reconstruction including Bentall procedure, David procedure, proximal aortic anastomosis, etc. are performed during the rewarming period. The patient is weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation are the same for all patients.
Follow-up Follow-up will be performed according to the institutional database supplemented by individual patient records. Data will be obtained via medical records of clinical encounters or phone calls with patients and/or relatives. Postoperative computed tomographic scans will be performed upon discharge, at 12 months from the last procedure and at 60 months thereafter.
- Conditions
- Ascending Aortic Aneurysm
- Being tested
- Full sternotomy, J-shaped mini-sternotomy
- Keywords
- ascending aortic aneurysm, aortic replacement, sternotomy, mini-sternotomy
- Medical subject headings
- Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full sternotomyProcedure or surgery
hemiarch repair via full sternotomy
J-shaped mini-sternotomyProcedure or surgery
hemiarch repair via J-shaped mini-sternotomy
| Study group | Role | What they receive |
|---|---|---|
| Full Sternotomy | Active comparator | 100 patients who will undergo hemiarch repair via full sternotomy Receives: Procedure: Full sternotomy |
| Mini J-Sternotomy | Active comparator | 100 patients who will undergo hemiarch repair via J-shaped mini-sternotomy Receives: Procedure: J-shaped mini-sternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early mortality
The difference in the incidence of early mortality between groups (p-value).
Measured: during follow-up time - 60 months
Secondary outcomes (11)
Delirium (percent)
The difference in the incidence of delirium during follow-up (p-value).
Measured: Perioperative/Periprocedural
Transient ischemic attack (percent)
The difference in the incidence of transient ischemic attack during follow-up (p-value).
Measured: Perioperative/Periprocedural
Stroke (percent)
The difference in the incidence of stroke during follow-up (p-value).
Measured: during follow-up time - 60 months
Respiratory failure (percent)
The difference in the incidence of respiratory failure during follow-up (p-value).
Measured: Perioperative/Periprocedural
New arrythmia (percent)
The difference in the incidence of new arrythmia during follow-up (p-value).
Measured: during follow-up time - 60 months
Pericardial effusion (percent)
The difference in the incidence of new arrythmia during follow-up (p-value).
Measured: Perioperative/Periprocedural
Heart failure (percent)
The difference in the incidence of heart failure during follow-up (p-value).
Measured: during follow-up time - 60 months
Myocardial infarction (percent)
The difference in the incidence of myocardial infarction during follow-up (p-value).
Measured: during follow-up time - 60 months
Systemic embolism (percent)
The difference in the incidence of systemic embolism during follow-up (p-value).
Measured: during follow-up time - 60 months
Acute kidney injury requiring renal replacement therapy (percent)
The difference in the incidence of renal replacement therapy during follow-up (p-value).
Measured: during follow-up time - 60 months
Re-exploration rate (percent)
The difference in the incidence of re-operation for bleeding during follow-up (p-value).
Measured: during follow-up time - 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Jul 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk Cardiology Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris N. Kozlov, MD, PhD, Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386028
- Sponsor's protocol ID
- 260
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology
- ClinicalTrials.gov ID
- NCT07386028
- Acronym / sponsor ID
- 260
- Conditions
- Ascending Aortic Aneurysm
- Keywords
- ascending aortic aneurysm, aortic replacement, sternotomy, mini-sternotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tomsk Cardiology Research InstituteUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Relevance of the study Hemiarch repair is an effective treatment for patients with ascending aortic aneurysm (AAR). All aortic procedures are routinely performed from full mean sternotomy but nowadays this standard could be performed via minimally invasive approach as well. There are some data that mini-J sternotomy is associated with less blood loss and blood products transfusion, improved lung function and eliminates wound complications risks. The aim of this study was to assess the morbidity and mortality after hemiarch repair via full or J-shaped mini-sternotomy.
- Patients and methods Patients who will undergo hemiarch repair procedure via full sternotomy (FS group) will be compared with patients who will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Baseline characteristics including preoperative clinical status, details on surgery, and postoperative outcomes will be compared between these groups. Follow-up data will be recorded.
Imaging All aortic measurements will be assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta will be performed within 2 weeks after surgery. Analysis will be performed using 64-slice scanner Discovery NM-CT 570c (GE Healthcare, Milwaukee, WI, USA) with spatial resolution of the angiographic phase ranging from 0.6 to 1.25 mm. All measurements will be taken always in the plane perpendicular to the manually corrected local aortic centre line. Ascending aortic diameter will be measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm) will be measured from the outer contours of the aortic wall. All images will be independently assessed by two experienced cardiologists.
Surgical technique The hemiarch repair is performed via a full sternotomy or J-shaped mini-sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion through the innominate artery with side graft. The distal aortic anastomosis is performed using an open anastomosis fashion and involved resection of the inferior portion of the aortic arch from the base of the innominate artery to the projection of the origin of the left subclavian artery. Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) is used for cerebral monitoring during the operation. When the target temperature is achieved, lower body circulatory arrest with antegrade cerebral perfusion is initiated. The distal aortic anastomosis is performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic reconstruction including Bentall procedure, David procedure, proximal aortic anastomosis, etc. are performed during the rewarming period. The patient is weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation are the same for all patients.
Follow-up Follow-up will be performed according to the institutional database supplemented by individual patient records. Data will be obtained via medical records of clinical encounters or phone calls with patients and/or relatives. Postoperative computed tomographic scans will be performed upon discharge, at 12 months from the last procedure and at 60 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Sternotomy | Active comparator | Procedure: Full sternotomy100 patients who will undergo hemiarch repair via full sternotomy |
| Mini J-Sternotomy | Active comparator | Procedure: J-shaped mini-sternotomy100 patients who will undergo hemiarch repair via J-shaped mini-sternotomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent.
- Ascending aorta greater than 5 cm without involving the aortic arch
Key exclusion criteria (4 listed)
- Acute aortic dissection or urgent/emergent cases.
- Redo aortic surgery.
- Aortic arch surgery.
- Concomitant CABG or left ventricle restoration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full sternotomyhemiarch repair via full sternotomy | Procedure or surgery | Full Sternotomy |
| J-shaped mini-sternotomyhemiarch repair via J-shaped mini-sternotomy | Procedure or surgery | Mini J-Sternotomy |
Primary outcome
Early mortality
Time frame: during follow-up time - 60 months
The difference in the incidence of early mortality between groups (p-value).
11 secondary outcomes
Delirium (percent)
Time frame: Perioperative/Periprocedural
Transient ischemic attack (percent)
Time frame: Perioperative/Periprocedural
Stroke (percent)
Time frame: during follow-up time - 60 months
Respiratory failure (percent)
Time frame: Perioperative/Periprocedural
New arrythmia (percent)
Time frame: during follow-up time - 60 months
Pericardial effusion (percent)
Time frame: Perioperative/Periprocedural
Heart failure (percent)
Time frame: during follow-up time - 60 months
Myocardial infarction (percent)
Time frame: during follow-up time - 60 months
Systemic embolism (percent)
Time frame: during follow-up time - 60 months
Acute kidney injury requiring renal replacement therapy (percent)
Time frame: during follow-up time - 60 months
Re-exploration rate (percent)
Time frame: during follow-up time - 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Enrolling by invitationObservational study
Bicuspid Aortic Valve (BAV) Registry
Bicuspid Aortic Valve
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Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Boris N. Kozlov, MD, PhD principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full sternotomy and J-shaped mini-sternotomy in people with Ascending Aortic Aneurysm, run by Tomsk Cardiology Research Institute at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitri S. Panfilov, MD, PhD (+79039130879, pand2006@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early mortality (time frame: during follow-up time - 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.