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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Dmitri S. Panfilov, MD, PhD contact

+79039130879

pand2006@yandex.ru

Andrey V. Sofronov contact

+79521542201

andreysofronov@mail.ru

Russia1 site, 1 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

    Recruiting

Other trials in Russia

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
  1. 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.
  2. 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.

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 groups in NCT07386028
Study groupRoleWhat they receive
Full SternotomyActive comparator100 patients who will undergo hemiarch repair via full sternotomy
Receives: Procedure: Full sternotomy
Mini J-SternotomyActive comparator100 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.

  1. Early mortality

    The difference in the incidence of early mortality between groups (p-value).

    Measured: during follow-up time - 60 months

Secondary outcomes (11)
  1. Delirium (percent)

    The difference in the incidence of delirium during follow-up (p-value).

    Measured: Perioperative/Periprocedural

  2. Transient ischemic attack (percent)

    The difference in the incidence of transient ischemic attack during follow-up (p-value).

    Measured: Perioperative/Periprocedural

  3. Stroke (percent)

    The difference in the incidence of stroke during follow-up (p-value).

    Measured: during follow-up time - 60 months

  4. Respiratory failure (percent)

    The difference in the incidence of respiratory failure during follow-up (p-value).

    Measured: Perioperative/Periprocedural

  5. New arrythmia (percent)

    The difference in the incidence of new arrythmia during follow-up (p-value).

    Measured: during follow-up time - 60 months

  6. Pericardial effusion (percent)

    The difference in the incidence of new arrythmia during follow-up (p-value).

    Measured: Perioperative/Periprocedural

  7. Heart failure (percent)

    The difference in the incidence of heart failure during follow-up (p-value).

    Measured: during follow-up time - 60 months

  8. Myocardial infarction (percent)

    The difference in the incidence of myocardial infarction during follow-up (p-value).

    Measured: during follow-up time - 60 months

  9. Systemic embolism (percent)

    The difference in the incidence of systemic embolism during follow-up (p-value).

    Measured: during follow-up time - 60 months

  10. 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

  11. 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.

  1. First posted4 Feb 2026
  2. Study start10 Jul 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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

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.

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