CRATOS
Research type
Research Study
Full title
Evaluation of Cratos Branch Stent Graft System in Treatment of Descending Aorta lesions
IRAS ID
334582
Contact name
Christoph Nienaber
Contact email
Sponsor organisation
Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-ID, 23-05-043114
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Summary of Research
Type B aortic dissection means there is tear in the aorta. Because of this dissection, blood flows through the tear and causes different layers in the aorta to separate. In some cases, there is a presence of intramural haematoma (IMH) or penetrating aortic ulcer (PAU). IMH is a swelling caused by accumulated blood within the layers in the aorta. PAU is a hardening of the arteries that form an ulcer penetrating the aortic wall.
The blood flow will be diverted to the tissue layers and can cause the aorta to rupture. This is a life-threatening condition that needs urgent surgical treatment.
Endovascular stent-graft repair (EVAR) is a treatment where a stent-graft is used to repair the aorta from within. The stent-graft is a synthetic fabric tube supported by metal wires. It is inserted to the body through a small incision in the groin. A catheter, with the stent-graft attached, is then delivered into the aorta under x-ray guidance. Once the stent-graft is in place it opens, covers and provides reinforcement to the weak area in the aorta.
When implanting the stent-graft, there is often a need to restore potentially restricted or blocked blood flow in the left subclavian artery (LSA). This artery starts from the aortic arch and moves oxygen-rich blood from the heart to the upper body. It is a major supplier of blood to your neck, head, and arms. During revascularisation of the LSA there is a risk of stroke or bleeding.
CratosTM Thoracic Branch Stent Graft System allows both the EVAR and LSA revascularisations to be performed in a single procedure in patients diagnosed with a Type B aortic dissection; IMH or PAU.
The objective of the study is to evaluate the efficacy and safety of CratosTM Branch Stent Graft System in treating lesions in descending aorta.Summary of Results
This study tested a medical device called the Cratos™ stent graft — a small metal mesh tube covered in fabric — used to treat serious conditions of the main artery in the chest (the aorta). The conditions treated included aortic dissection (where the artery wall tears and splits), bleeding within the artery wall (intramural haematoma), and deep ulcers in the artery wall (penetrating aortic ulcer).
The device was implanted using keyhole techniques, avoiding open surgery, and was specially designed to keep blood flowing to the left arm while repairing the aorta.
Twenty-six patients took part across international hospital sites. The main goal was to check whether patients were still alive 30 days after the procedure — all 26 were. One patient died later in the study, but this was unrelated to the device or procedure.
The device was successfully placed in every patient. Two patients developed a new tear near the device (a known possible complication); one needed further treatment and one was managed with medication and monitoring. No unexpected safety concerns were identified.The Creation study was terminated early with a total of 11 patients in Cohort 1 and 8 patient in Cohort 2. The study to date shows that there was technical success in placing the graft and that there were no safety issues detected during the short follow up that ensued. The product will continue to be marketed as a custom made product in Europe.
REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0219
Date of REC Opinion
12 Jun 2024
REC opinion
Further Information Favourable Opinion