Study on the Aortic Arch Single Branch Stent Graft System
ConditionAortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years, gender unrestricted.
Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.
The diameter range of the proximal aortic landing zone is 20-42 mm.
The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.
Disqualifiers
Previously undergone endovascular interventional treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects the implantation and evaluation of the single branched covered stent system of the aortic arch.
Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent covered stents from adhering to the vessel wall or affect stent patency.
Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).
Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.
Trial design
Design model
Single group
Treatments tested in this trial
Aortic Arch Single Branch Covered Stent System
Deviceto Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Treatment groups
135 Participants
are divided into 1 treatment groupGroup A: Aortic Arch Single Branch Covered Stent SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence rate for freedom from major adverse events (MAE) within 30 days postoperatively
Major adverse events refer to the occurrences of all-cause death, myocardial infarction, renal failure, liver failure, respiratory failure, paraplegia, ischemic stroke, intestinal necrosis. Among them, renal failure means that it leads to persistent dialysis, kidney transplantation, or other fatal outcomes. Respiratory failure means that it leads to a significantly prolonged intubation time, tracheotomy, deterioration of lung function, or other fatal outcomes. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal outcomes.
Time frame
pre-discharge up to 14 days and 30 days post-surgery2
Procedural success rate of aortic dissection treatment 12 months postoperatively
The composite endpoints include immediate technical success post-procedure and, at the 12-month CTA reexamination, the absence of displacement of the main aortic and branch stents, no type I or III endoleaks, patency of the branch stents, and no secondary surgical interventions during follow-up.
Time frame
intraoperative and 12 months postoperativelySecondary outcomes
1
All-cause mortality
All-cause mortality Refers to deaths from any cause that occur within the follow-up time points.
Time frame
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively2
Mortality rate related to aortic dissection
Mortality rate related to aortic dissection refers to the death caused by the rupture of aortic dissection or the endovascular treatment of aortic dissection.
Time frame
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively3
Incidence rate of severe adverse events
Serious adverse events refer to those occurring during the process of a clinical trial that lead to death or a serious deterioration of the health condition. This includes fatal diseases or injuries, permanent defects in body structures or body functions, the need for hospitalization or an extended hospital stay, and the requirement for medical or surgical interventions to prevent permanent defects in body structures or body functions.
Time frame
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperatively4
Incidence rate of Device-related adverse events
Adverse events refer to adverse medical events that occur during the process of a clinical trial, regardless of whether they are related to the medical device used in the trial. However, normal postoperative stress responses should be distinguished, such as fever, discomfort in the chest and back, etc. If, upon the judgment of the researcher, it is determined to be a normal postoperative stress response, there is no need to record it as an adverse event of the medical device. Adverse events related to the medical device refer to situations that are determined by the researcher to be definitely related, possibly related, or undeterminable in relation to the medical device used in the trial.
Time frame
Pre-discharge up to 14 days, 30 days post-surgery, 6 and 12 months and 2-5 years postoperativelySponsors and contacts
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Source ClinicalTrials.gov