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Trial registered on ANZCTR


Registration number
ACTRN12618001329257
Ethics application status
Approved
Date submitted
31/07/2018
Date registered
7/08/2018
Date last updated
7/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
Distal aortic remodeling after standard and elongated frozen elephant trunk procedure in patients with aortic dissection
Secondary ID [1] 295696 0
None
Universal Trial Number (UTN)
U1111-1218-3103
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aortic dissection 309075 0
aortic remodeling 309076 0
Condition category
Condition code
Cardiovascular 307956 307956 0 0
Other cardiovascular diseases
Surgery 308022 308022 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 302015 0
Treatment: Surgery
Intervention code [2] 312069 0
Treatment: Devices
Comparator / control treatment
Control group: antegrade implantation of the hybrid ctent graft combined with open aortic arch surgery (frozen elephant trunk procedure only).
The stent graft (mean diameter of 22-40 mm and a length of 150 mm ) was inserted into the descending thoracic aorta without a guidewire and in most cases was attached by continuous suturing with 4-0 polypropylene sutures distal to the left subclavian artery. In several cases, the stent graft proximal anastomosis was performed in other zones. Transesophageal echocardiography monitoring was used during the stent graft deployment. After distal anastomosis, a clamp was placed on the aortic prosthesis, systemic blood perfusion was resumed through an additional cannula, which was inserted into the prostheses distal to the clamp, and the patient was gradually rewarmed. Supra-aortic vessel reconstruction was performed in an “en bloc” fashion or separately. The unilateral cerebral perfusion was then discontinued. The proximal aortic anastomosis was then carried out, and the coronary blood flow was restored.
Intervention: In addition to the above, an additional stent graft is implanted into the descending aorta to the level of the celiac trunk, which allows to cover a longer section of the aorta
Control group
Active

Outcomes
Primary outcome [1] 306933 0
All cause mortality.
Timepoint [1] 306933 0
Baseline, 6 months (primary timepoint), 12-24-36-48-60 months after intervention commencement. Data were collected through calls to patients, their relatives, email, call for hospitalization hospital subject to availability of the patient
Primary outcome [2] 306934 0
Aortic remodeling
Timepoint [2] 306934 0
Baseline, 6 months (primary timepoint), 12-24-36-48-60 months after intervention commencement. Data were collected by performing a CT of the operated patients
Primary outcome [3] 306935 0
aortic re-intervention
Timepoint [3] 306935 0
Baseline, 6 months (primary timepoint), 12-24-36-48-60 months after intervention commencement. Data were collected by performing a CT of the operated patients
Secondary outcome [1] 350151 0
Neurological deficit
Timepoint [1] 350151 0
30 days post commencement of intervention. The presence of neurological deficit was determined by clinically regular neurologist. Followed by CT or MRI of the brain to confirm or refute the diagnosis
Secondary outcome [2] 350152 0
Spinal cord ischemia
Timepoint [2] 350152 0
30 days post commencement of intervention. The presence of spinal cord ischemia was determined by clinically regular neurologist. Followed by CT or MRI of the brain to confirm or refute the diagnosis

Eligibility
Key inclusion criteria
Aortic dissection (De Bakey I and III types) that propagates down to aortic bifurcation
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A dissection flap limited to the aortic arch or to the proximal descending aorta

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
7/03/2012
Date of last participant enrolment
Anticipated
Actual
27/11/2017
Date of last data collection
Anticipated
25/12/2022
Actual
Sample size
Target
30
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 10718 0
Russian Federation
State/province [1] 10718 0
Tomsk region

Funding & Sponsors
Funding source category [1] 300282 0
Hospital
Name [1] 300282 0
Cardiology Research Institute, Tomsk National Research Medical Center
Country [1] 300282 0
Russian Federation
Primary sponsor type
Hospital
Name
Cardiology Research Institute, Tomsk National Research Medical Center
Address
Kievskaya st, 111a, Tomsk
Country
Russian Federation
Secondary sponsor category [1] 299712 0
None
Name [1] 299712 0
None
Address [1] 299712 0
Country [1] 299712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301093 0
Committee on biomedical ethics of Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Science
Ethics committee address [1] 301093 0
Kievskaya Street 111a., Tomsk, 634012, Russia
Ethics committee country [1] 301093 0
Russian Federation
Date submitted for ethics approval [1] 301093 0
Approval date [1] 301093 0
29/03/2018
Ethics approval number [1] 301093 0

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85862 0
Dr Kozlov Boris
Address 85862 0
Cardiology Research Institute, Tomsk National Research Medical Center
Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 85862 0
Russian Federation
Phone 85862 0
+7 3822 555 483
Fax 85862 0
+7 3822 555 483
Email 85862 0
bnkozlov@yandex.ru
Contact person for public queries
Name 85863 0
Panfilov Dmitriy
Address 85863 0
Cardiology Research Institute, Tomsk National Research Medical Center
Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 85863 0
Russian Federation
Phone 85863 0
+7 3822 555 483
Fax 85863 0
+7 3822 555 483
Email 85863 0
pand2006@yandex.ru
Contact person for scientific queries
Name 85864 0
Panfilov Dmitriy
Address 85864 0
Cardiology Research Institute, Tomsk National Research Medical Center
Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 85864 0
Russian Federation
Phone 85864 0
+7 3822 555 483
Fax 85864 0
+7 3822 555 483
Email 85864 0
pand2006@yandex.ru

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What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23667Informed consent form   

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