LSA Reconstruction With Laser Fenestration During the TEVAR

NCT03845829 | Completed Results DMC

• 1 other identifier: AAL01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type B Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Aortic Disease Related Mortality

  12 months

• Incidence of Endoleak Within 12 Months After Procedure

  12 months

• Technical Success Rate During the Procedure

  During the procedure

• Patency Rate of Branches Stents 12 Months After Procedure

  12 months

Study Arms (1)

Patients with TBAD treated with TEVAR

EXPERIMENTAL

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

Procedure: In situ laser assisted fenestration

Interventions

In situ laser assisted fenestration PROCEDURE

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

Patients with TBAD treated with TEVAR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Life expectancy of \< 5 years;
• Patients need open surgery repair for the aortic diseases.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Kaichuang Ye

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• Peng Z, Liang S, Zhang R, Qiu P, Yin M, Liu G, Liu X, Lu X, Ye K. Left Subclavian Artery Revascularization With In Situ Laser Fenestration During Thoracic Endovascular Aortic Repair for Acute Complicated or High-Risk Type B Aortic Dissection: Results of the LLTEVAR Trial. J Am Heart Assoc. 2025 Dec 16;14(24):e041720. doi: 10.1161/JAHA.125.041720. Epub 2025 Dec 10.

  PMID: 41368828 DERIVED

Results Point of Contact

• Title: Kaichuang Ye
• Organization: Department of Vascular Surgery, Shanghai Ninth People's Hospital

ykaichuang@163.com

+86-021-2327166

Study Officials

• Kaichuang Ye, MD, PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Vascular Surgery

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 19, 2019
• Study Start: July 1, 2018
• Primary Completion: December 10, 2022
• Study Completion: November 20, 2023
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)