LSA Reconstruction With Laser Fenestration During the TEVAR (LLTEVAR)

Shanghai Jiao Tong University

Status: Completed

Conditions: Type B Aortic Dissection

Treatments: Procedure: In situ laser assisted fenestration

Study type: Interventional

Funder types: Other

Identifiers

NCT03845829

AAL01

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patients with TBAD treated with TEVAR

Experimental group

Description:

In situ laser assisted fenestration for the left subclavian artery during the TEVAR procedure for TBAD.

Treatment:

Procedure: In situ laser assisted fenestration