Full sternotomy versus J-shaped mini-sternotomy for hemiarch repair of the ascending aorta
Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology
This compares outcomes of full sternotomy and J-shaped mini-sternotomy in adults having hemiarch repair for an ascending aortic aneurysm to see which approach leads to better early and late recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tomsk Cardiology Research Institute Academic / other |
| Locations | 1 site (Tomsk) |
| Trial ID | NCT07386028 on ClinicalTrials.gov |
What this trial studies
This interventional comparison enrolls 200 patients with chronic ascending aortic aneurysm who meet criteria for elective hemiarch repair (ascending aorta >5 cm without arch involvement). One hundred patients will undergo hemiarch repair via full median sternotomy and 100 via a J-shaped mini-sternotomy, with baseline, operative, and postoperative data recorded. Imaging uses ECG-gated CT angiography preoperatively and within two weeks postoperatively with standardized measurements perpendicular to the aortic centerline. Early perioperative outcomes (blood loss, transfusion, lung function, wound complications, morbidity, mortality) and longer-term follow-up outcomes will be compared between the two groups.
Who should consider this trial
Good fit: Adults with a chronic ascending aortic aneurysm and an ascending aorta diameter greater than 5 cm limited to the ascending aorta who are scheduled for elective hemiarch repair and can give informed consent.
Not a fit: Patients with acute aortic dissection, urgent/emergent cases, redo aortic surgery, aortic arch involvement, or who require concomitant CABG or left ventricular restoration are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the mini-sternotomy approach could reduce blood loss, transfusions, respiratory complications and wound problems, enabling faster recovery and shorter hospital stays.
How similar studies have performed: Previous nonrandomized reports of J-shaped mini-sternotomy in aortic surgery have shown reduced blood loss and faster respiratory recovery, but evidence specific to hemiarch repair remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tomsk
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia — Tomsk, Russia (Recruiting)
Study contacts
- Principal investigator: Boris N. Kozlov, MD, PhD — Cardiology Research Institute, Tomsk National Research Medical Center
- Study coordinator: Dmitri S. Panfilov, MD, PhD
- Email: pand2006@yandex.ru
- Phone: +79039130879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.