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
Qualifiers
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
Treatments tested in this trial
- Aortic Arch Single Branch Covered Stent System
Treatment groups
135 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov