Type B Aortic Dissection Clinical Trial
— LLTEVAROfficial title:
Left Subclavian Artery Reconstruction With Laser-assisted Fenestration During the Procedure of Thoracic EndoVascular Aortic Repair for Type B Aortic Dissection
This study aims to evaluate the feasibility, effectiveness, and safety of in-situ laser-assisted fenestration on the left subclavian artery during the procedure of thoracic artery endovascular repair
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male or non-pregnant female over 18 years of age; - Type B Aortic Dissection; - The left subclavian artery should be reconstructed during the TEVAR procedure. - Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule and medication regimen; Exclusion Criteria: - Life expectancy of < 5 years; - Patients need open surgery repair for the aortic diseases. |
Country | Name | City | State |
---|---|---|---|
China | Kaichuang Ye | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from all-cause reintervention, all-cause mortality and major adverse events | Freedom from all-cause reintervention, all-cause mortality and major adverse events | 12 months post-procedure | |
Secondary | Aortic disease related mortality | Aortic disease related mortality | 12 months | |
Secondary | Incidence of endoleak | Incidence of endoleak | 12 months | |
Secondary | Incidence of endoleak | Incidence of endoleak | 24 months | |
Secondary | Technical success rate | Technical success rate | During the procedure | |
Secondary | Patency rate of branches stents | Patency rate of branches stents | 12 months | |
Secondary | Patency rate of branches stents | Patency rate of branches stents | 24 months |
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