N/A
Completed N=100
LSA Reconstruction With Laser Fenestration During the TEVAR
Source: ClinicalTrials.gov NCT03845829 ↗Enrolled (actual)
100
Serious AEs
16.0%
Results posted
Feb 2025
Primary outcomePrimary: Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure — 84 Participants
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
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 | — |
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.
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. Informational only — not medical advice.