N/A N=100 Treatment

LSA Reconstruction With Laser Fenestration During the TEVAR

Type B Aortic Dissection

Bottom Line

View on ClinicalTrials.gov: NCT03845829 ↗

Enrolled (actual)

100

Serious AEs

16.0%

Results posted

Feb 2025

Primary outcome: Primary: Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure — 84 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: In situ laser assisted fenestration (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure	84	—
SECONDARY Aortic Disease Related Mortality	—	—
SECONDARY Incidence of Endoleak Within 12 Months After Procedure	2; 2; 4; 1	—
SECONDARY Technical Success Rate During the Procedure	98	—
SECONDARY Patency Rate of Branches Stents 12 Months After Procedure	98	—

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03845829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.