Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000123943
Ethics application status
Approved
Date submitted
28/11/2019
Date registered
10/02/2020
Date last updated
10/02/2020
Date data sharing statement initially provided
10/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
What frozen elephant trunk prosthesis is safe and effective in the treatment thoracic aortic disease
Scientific title
Comparison of two frozen elephant trunk prostheses in the treatment thoracic aortic disease
Secondary ID [1] 299943 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
thoracic aortic aneurysm 315392 0
thoracic aortic dissection 315393 0
Condition category
Condition code
Cardiovascular 313688 313688 0 0
Other cardiovascular diseases
Surgery 313689 313689 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be operated on for both thoracic aortic aneurysm and dissection using hybrid stent-graft (E-vita open plus or MedEng graft).
Both grafts have the same lenth the stented part is 150 mm and nonstented part is 70 mm. The main difference is perfusion branch which has the MedEng graft (8 mm in diameter and 5 cm long). Besides, MedEng graft differs from E-vita in the pattern of the stented part, which is aimed at reducing the radial lforce. All data will be prospectively collected and recorded. All surgeries will be perform concurrently in the same time period. Experienced in aortic pathology surgeons will perform these operations.

Description of the graft:
Both hybrid stent-grafts are consist of 2 parts: stented and stentless. Stented part is 15 cm long in both prostheses. Stentless part is about 10 cm long. Both prostheses are available at different sizes from 22 mm to 40 mm in diametre.

Description of the procedures:
Surgical access is obtained through a median sternotomy. Aortic surgery will be conducted under cardiopulmonary bypass (CPB) and MHCA with unilateral ACP via innominate artery with a flow rate of 8–10 ml/kg/min and perfusion pressure of 60–80 mmHg. Perfusion adequacy will be evaluated using measurement of blood pressure in both radial arteries and cerebral oximetry using near-infrared spectroscopy. Once CPB will be instituted, the aortic cross-clamp will apply, and the heart will be arrest with antegrade cardioplegia. After gradual cooling and when rectal temperature (28 degrees C), the circulatory arrest will be initiated.
After this the stent graft is inserted into the descending thoracic aorta without a guidewire and is attached by continuous suturing with 4-0 polypropylene sutures distal to the left subclavian artery (zone 3) or common left carotid artery (zone 2). Transesophageal echocardiography monitoring is used during the stent graft deployment. After distal anastomosis, a clamp is placed on the aortic prosthesis, systemic blood perfusion is resumed through an additional cannula, which is inserted into the prostheses distal to the clamp, and the patient is gradually rewarmed. Supra-aortic vessel reconstruction is performed in an “en bloc” fashion or separately.


Audit of nurse notes (arterial pressure in both radial arteries, NIRS, body temperature), perfusion records (perfusion rate and perfusion pressure during both of cardiopulmonary bypass and unilateral cerebral perfusion in Hemiarch procedure, blood temperature, haemohydrobalance), blood tests (acid-base indices, total and biochemical blood tests) were performed to assess or monitor fidelity to the surgery.

Follow-up information will be collected using direct or phone contact with patients, relatives, or physicians. All survived patients will be underwent a clinical follow-up examination and aortic evaluation by CT scan before discharge, at 6 and 12 months postoperatively, and annually thereafter.
Intervention code [1] 316211 0
Treatment: Surgery
Intervention code [2] 316212 0
Treatment: Devices
Comparator / control treatment
The total patient population will be randomazed into 2 groups. The first group of the patients will recive the implantation of the E-vita open plus graft (main group). The second group of the patients will recieve implantation of the MedEng graft (control group).
Control group
Active

Outcomes
Primary outcome [1] 322118 0
Operative mortality as assessed by data linkage to medical records
Timepoint [1] 322118 0
During the first 30 days after the procedure
Primary outcome [2] 322119 0
all-cause mortality as assessed by data linkage to medical records or or phone contact with relatives or physicians
Timepoint [2] 322119 0
Up to 5 years (post-discharge)
Secondary outcome [1] 377416 0
Incidence of the myocardial infarction was assessed by complex evaluation based on the ECG and echocardiographic changes as well as increase of the troponin level using serum assay
Timepoint [1] 377416 0
During the first 30 days after the procedure (assessed by daily serum assay and ECG in the ICU and every 5 days after discharge from ICU. )
Secondary outcome [2] 377417 0
Permament neurological deficit was defined as stroke, coma, or any new focal neurologic deficit that persisted >48 hours, accompanied by computed tomography or magnetic resonance imaging findings confirming a new brain injury
Timepoint [2] 377417 0
During the first 30 days after the procedure (single assessment by CT or MRI. More often if necessary)
Secondary outcome [3] 377418 0
New onset of the renal insufficiency (acute renal failure) requiring haemodialysis during ICU stay of the patient. An increase in the serum creatinine to >3.0 mg/dL and/or a >2-fold increase in the most recent preoperative creatinine level were indications for haemodyalisis. (assessed by serum assay)
Timepoint [3] 377418 0
during the first 30 days after the procedure (daily serum assay in the ICU and every 5 days after discharge from ICU)
Secondary outcome [4] 377419 0
Respiratory failure (artificial ventilation for more than 72 hours) requiring tracheostomy during ICU stay of the patient as assesed by data linkage to medical records
Timepoint [4] 377419 0
During the first 30 days after the procedure

Eligibility
Key inclusion criteria
Patients with thoracic aortic aneuysm and dissection (type A and B)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Oncological disease (high degrees)
Severe chronic heart failure
Refusal of surgical treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analyses were performed using R 1.0.136, (RStudio, Inc., USA). Categorical variables are summarized as n (%). Continuous data that follow a Gaussian distribution are described as mean ± standard deviation. Continuous data that follow a non-Gaussian distribution are described as a sample median with the respective 25th and 75th percentiles. Baseline characteristics are compared using t tests for continuous variables and chi-square tests for categorical variables (Fisher’s exact tests when necessary due to small cell sizes). Immediate perioperative and postoperative outcomes are also compared using t tests for continuous variables and Fisher’s exact tests for categorical variables. Survival and freedom from re-intervention for each group is presented using Kaplan-Meier curves. Statistical differences in the survival distributions were assessed using the log-rank test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 22152 0
Russian Federation
State/province [1] 22152 0
Tomsk region

Funding & Sponsors
Funding source category [1] 304407 0
Hospital
Name [1] 304407 0
Cardiology Research Institute, Tomsk National Research Medical Center
Country [1] 304407 0
Russian Federation
Primary sponsor type
Hospital
Name
Cardiology Research Institute, Tomsk National Research Medical Center
Address
634012, Kievskaya st, 111a, Tomsk, Russia
Country
Russian Federation
Secondary sponsor category [1] 304665 0
None
Name [1] 304665 0
Address [1] 304665 0
Country [1] 304665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304843 0
Committee on biomedical ethics of Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Science
Ethics committee address [1] 304843 0
Ethics committee country [1] 304843 0
Russian Federation
Date submitted for ethics approval [1] 304843 0
Approval date [1] 304843 0
14/02/2019
Ethics approval number [1] 304843 0
# 167

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98386 0
Dr Kozlov Boris
Address 98386 0
Cardiology Research Institute, Tomsk National Research Medical Center Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 98386 0
Russian Federation
Phone 98386 0
+7 3822 555 483
Fax 98386 0
+7 3822 555 483
Email 98386 0
[email protected]
Contact person for public queries
Name 98387 0
Dmitri Panfilov
Address 98387 0
Cardiology Research Institute, Tomsk National Research Medical Center Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 98387 0
Russian Federation
Phone 98387 0
+7 3822 555 483
Fax 98387 0
+7 3822 555 483
Email 98387 0
[email protected]
Contact person for scientific queries
Name 98388 0
Dmitri Panfilov
Address 98388 0
Cardiology Research Institute, Tomsk National Research Medical Center Kievskaya st, 111a, Tomsk, 634012, Russia.
Country 98388 0
Russian Federation
Phone 98388 0
+7 3822 555 483
Fax 98388 0
+7 3822 555 483
Email 98388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data cannot be submitted under patient confidentiality laws


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.