Skip to main content
OpenTrials
Completed

NCT Number: NCT03845829

LSA Reconstruction With Laser Fenestration During the TEVAR

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type B Aortic Dissection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaichuang Ye

Shanghai, Shanghai Municipality, 200011, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Aortic Disease Related Mortality

    Time frame: 12 months

    the incident of death associated with aortic disease.

  2. Incidence of Endoleak Within 12 Months After Procedure

    Time frame: 12 months

    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.

  3. Technical Success Rate During the Procedure

    Time frame: During the procedure

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

  4. Patency Rate of Branches Stents 12 Months After Procedure

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: LLTEVAR

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Feb 19, 2019
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.