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What frozen elephant trunk prosthesis is safe and effective in the treatment thoracic aortic disease

Comparison of two frozen elephant trunk prostheses in the treatment thoracic aortic disease

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000123943
Enrollment
50
Registered
2020-02-10
Start date
2020-03-02
Completion date
Unknown
Last updated
2020-02-17

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 our study is to analyze the immediate and long-term results of different types of the hybrid stent grafts (E-vita open plus versus MedEng -graft) in patients with thoracic aortic aneurysm and dissection (Type A and B). It is hypothesized that there is both prostheses is safe in the early postoperative period and has the same efficacy. For this purpose all of the patient population will be randomized into 2 groups . The first group of the patients will receive implanattion of the E-vita open plus hybrid graft. And the second group will receive the implantation of the MedEng graft .

Interventions

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 r

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.

Sponsors

Cardiology Research Institute, Tomsk National Research Medical Center
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

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

Inclusion criteria

Patients with thoracic aortic aneuysm and dissection (type A and B)

Exclusion criteria

Oncological disease (high degrees) Severe chronic heart failure Refusal of surgical treatment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026