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NCT Number: NCT07386028

Full Sternotomy vs Mini-sternotomy for 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia

Tomsk, 634012, Russia

Location status: Recruiting

Location contact

Dmitri S. Panfilov, MD, PhD

CONTACT

[email protected]

+79039130879

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent.
  • Ascending aorta greater than 5 cm without involving the aortic arch

Exclusion criteria

  • Acute aortic dissection or urgent/emergent cases.
  • Redo aortic surgery.
  • Aortic arch surgery.
  • Concomitant CABG or left ventricle restoration

Treatment and study plan

Full sternotomy

Procedure

hemiarch repair via full sternotomy

J-shaped mini-sternotomy

Procedure

hemiarch repair via J-shaped mini-sternotomy

Primary outcomes

  1. Early mortality

    Time frame: during follow-up time - 60 months

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

Secondary outcomes

  1. Delirium (percent)

    Time frame: Perioperative/Periprocedural

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

  2. Transient ischemic attack (percent)

    Time frame: Perioperative/Periprocedural

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

  3. Stroke (percent)

    Time frame: during follow-up time - 60 months

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

  4. Respiratory failure (percent)

    Time frame: Perioperative/Periprocedural

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

  5. New arrythmia (percent)

    Time frame: during follow-up time - 60 months

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

  6. Pericardial effusion (percent)

    Time frame: Perioperative/Periprocedural

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

  7. Heart failure (percent)

    Time frame: during follow-up time - 60 months

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

  8. Myocardial infarction (percent)

    Time frame: during follow-up time - 60 months

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

  9. Systemic embolism (percent)

    Time frame: during follow-up time - 60 months

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

  10. Acute kidney injury requiring renal replacement therapy (percent)

    Time frame: during follow-up time - 60 months

    The difference in the incidence of renal replacement therapy during follow-up (p-value).

  11. Re-exploration rate (percent)

    Time frame: during follow-up time - 60 months

    The difference in the incidence of re-operation for bleeding during follow-up (p-value).

Study contacts

Contact information is provided by the study sponsor or research team.

Andrey V. Sofronov

CONTACT

[email protected]

+79521542201

Dmitri S. Panfilov, MD, PhD

CONTACT

[email protected]

+79039130879

Sponsors and collaborators

Lead sponsor

Tomsk Cardiology Research Institute

Other

Registry information

Official study title

Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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