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Frequency of the distal aortic remodeling after frozen elephant trunk (FET) only and elongated FET procedure (standard + TEVAR) in patients with aortic dissection propageted down to aortic bifurcation

Distal aortic remodeling after standard and elongated frozen elephant trunk procedure in patients with aortic dissection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001329257
Enrollment
26
Registered
2018-08-07
Start date
2012-03-07
Completion date
2017-11-27
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the present study was to study the effect on the frequency of abdominal aortic remodeling and distal reintreations of additional stent graft implantation in the distal part of the descending aorta after the previously implanted hybrid stent graft in the proximal descending aorta. For this purpose, two groups with aortic dissection extending to the bifurcation of the abdominal aorta were estimated comparable by the main clinical parameters. One group included patients who underwent only hybrid reconstruction of the thoracic aorta (open reconstruction of the aortic arch with simultaneous implantation of a hybrid stent graft into the proximal descending aorta). The other group included patients who, in addition to the previous intervention, were implanted with stent graft in the distal part of the descending aorta to the level of the celiac trunk (TEVAR).

Interventions

Brief name: Effect of the hybryd stent-graft (with or without TEVAR) deployment in the descending aorta. FET ("frozen elephant trunk") procedure includes open intervention on the aortic arch and simultaneous antegrade implantation of stent graft into the descending aorta under transesophageal ulrasonic control. All procedures were performed under cardiopulmonary bypass, circulatory arrest with unilateral antegrade cerebral perfusion via innominate artery Duration of the FET ("frozen elephant tr

Brief name: Effect of the hybryd stent-graft (with or without TEVAR) deployment in the descending aorta. FET ("frozen elephant trunk") procedure includes open intervention on the aortic arch and simultaneous antegrade implantation of stent graft into the descending aorta under transesophageal ulrasonic control. All procedures were performed under cardiopulmonary bypass, circulatory arrest with unilateral antegrade cerebral perfusion via innominate artery Duration of the FET ("frozen elephant trunk procedure") procedure individually in each case.On average, the procedure of reconstruction of the aortic arch and implantation of a stent graft is 60-120 minutes All procedures were performed by one experienced surgeon (25 years experience) Armamentarium: E-vita Open Plus graft (Jotec GmbH, Hechingen, Germany), E-vita thoracic 3G (Jotec GmbH, Hechingen, Germany) There are 2 groups of patients with aortic dissection (De Bakey I and III types) propagated down to aortic bifurcation: 1st - frozen elephant trunk procedure only (antergade implantation of the hybris stent graft in the descending aorta combined with open aortic arch surgery) 2nd - frozen elephant trunk procedure + TEVAR (down to coeliac trunk). TEVAR is performed during the first 30 days after primary FET Group division was random.

Sponsors

Cardiology Research Institute, Tomsk National Research Medical Center
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Aortic dissection (De Bakey I and III types) that propagates down to aortic bifurcation

Exclusion criteria

A dissection flap limited to the aortic arch or to the proximal descending aorta

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026