Health TrialsbyHealthPanel

Full Sternotomy vs Mini-sternotomy for Ascending Aortic Pathology

ConditionAscending Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTomsk Cardiology Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

Ascending aorta greater than 5 cm without involving the aortic arch

Disqualifiers

Acute aortic dissection or urgent/emergent cases.

Redo aortic surgery.

Aortic arch surgery.

Concomitant CABG or left ventricle restoration

Trial design

Design model

Parallel

Treatments tested in this trial

  • Full sternotomy

    Procedure/Surgery

    hemiarch repair via full sternotomy

  • J-shaped mini-sternotomy

    Procedure/Surgery

    hemiarch repair via J-shaped mini-sternotomy

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Full SternotomyActive comparator 1 intervention
Group B: Mini J-SternotomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Early mortality

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

Time frame
during follow-up time - 60 months

Secondary outcomes

1

Delirium (percent)

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

Time frame
Perioperative/Periprocedural
2

Transient ischemic attack (percent)

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

Time frame
Perioperative/Periprocedural
3

Stroke (percent)

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

Time frame
during follow-up time - 60 months
4

Respiratory failure (percent)

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

Time frame
Perioperative/Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tomsk Cardiology Research Institute

Lead sponsor

Source ClinicalTrials.gov
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