LSA Reconstruction With Laser Fenestration During the TEVAR

Type B Aortic Dissection Clinical Trial

— LLTEVAR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03845829
• Other study ID #: AAL01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aortic Dissection
• Type B Aortic Dissection

Intervention

Procedure:
• In situ laser assisted fenestration
In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection

Locations

Country	Name	City	State
China	Kaichuang Ye	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

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