LSA Reconstruction With Laser Fenestration During the TEVAR (LLTEVAR)

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

Study Overview

• Status: Completed
• Conditions: Type B Aortic Dissection
• Intervention / Treatment: Procedure: In situ laser assisted fenestration

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Kaichuang Ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with TBAD treated with TEVAR; In situ laser assisted fenestration for the left subclavian artery during the TEVAR procedure for TBAD.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 30 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic Disease Related Mortality	the incident of death associated with aortic disease.	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.	12 months
Technical Success Rate During the Procedure	Technical success of successful TEVAR procedure and the in-situ laser-assisted fenestration for LSA revascularization.	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.	12 months

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Kaichuang Ye, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: AAL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No