LSA Reconstruction With Laser Fenestration During the TEVAR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University100 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Type B Aortic Dissection

Interventions

In situ laser assisted fenestrationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kaichuang Ye

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure

The primary safety endpoint was freedom from major adverse events within 30 days after procedure. The major adverse events included mortality, stroke, myocardial infarction, rupture, paraplegia, type Ia endoleak, major bleeding, acute kidney injury, limb ischemia, bowel ischemia, retrograde dissection, stent-induced new entry (SINE), access site complications and unplanned reinterventions.

Time frame: within 30 days after procedure

Secondary Outcomes

Aortic Disease Related Mortality

the incident of death associated with aortic disease.

Time frame: 12 months

Incidence of Endoleak Within 12 Months After Procedure

During the follow up of 12 months after procedure, the total incidence of endoleaks. Type Ia endoleak is a perigraft leak at the proximal edge of the stent graft that allows continued antegrade flow into the false lumen through the primary entry tear. Type Ib endoleak is a distal perigraft leak caused by a tear in the intimal membrane adjacent to the distal edge of the endograft (distal stent graft-induced new entry, SINE). Type II endoleak is continued retrograde false lumen perfusion through an arch branch (eg, left subclavian artery as demonstrated in the illustration) or intercostal or bronchial artery. Type R endoleak is antegrade flow from the true lumen to the false lumen through septal, visceral, or distal fenestrations.

Time frame: 12 months

Technical Success Rate During the Procedure

Technical success of successful TEVAR procedure and the in-situ laser-assisted fenestration for LSA revascularization.

Time frame: During the procedure

Patency Rate of Branches Stents 12 Months After Procedure

Patency rate (less than 50% in-stent-restenosis) of the subclavian artery stents 12 months after procedure.

Data from ClinicalTrials.gov

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