LSA Reconstruction With Laser Fenestration During the TEVAR

Study Overview
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Brief Summary
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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

Detailed Description
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This study is a single-arm, prospective study. All patients with type B aortic dissection (TBAD) present with the proximal tear site located approximately close to the left subclavian artery and a reconstruction of the left subclavian artery is necessary are included in the present study. During the procedure of thoracic artery endovascular repair (TEVAR), the left subclavian artery will be reconstructed with laser-assisted fenestration and the fenestrated stent will be covered stents (fluency, viabhan, lifestream).

Official Title
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Left Subclavian Artery Reconstruction With Laser-assisted Fenestration During the Procedure of Thoracic EndoVascular Aortic Repair for Type B Aortic Dissection

Conditions
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Type B Aortic Dissection

Intervention / Treatment
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* Procedure: In situ laser assisted fenestration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with TBAD treated with TEVAR<br>In situ laser assisted fenestration for the left subclavian artery during the TEVAR procedure for TBAD. | Procedure: In situ laser assisted fenestration<br>* In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic disease related mortality | Aortic disease related mortality | 12 months | 
| Incidence of endoleak | Incidence of endoleak | 12 months | 
| Incidence of endoleak | Incidence of endoleak | 24 months | 
| Technical success rate | Technical success rate | During the procedure | 
| Patency rate of branches stents | Patency rate of branches stents | 12 months | 
| Patency rate of branches stents | Patency rate of branches stents | 24 months |