- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845829
LSA Reconstruction With Laser Fenestration During the TEVAR (LLTEVAR)
October 12, 2023 updated by: Kaichuang Ye, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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
Enrolling by invitation
Conditions
Intervention / Treatment
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 (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200011
- Kaichuang Ye
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
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
Time Frame: 12 months post-procedure
|
Freedom from all-cause reintervention, all-cause mortality and major adverse events
|
12 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aortic disease related mortality
Time Frame: 12 months
|
Aortic disease related mortality
|
12 months
|
Incidence of endoleak
Time Frame: 12 months
|
Incidence of endoleak
|
12 months
|
Incidence of endoleak
Time Frame: 24 months
|
Incidence of endoleak
|
24 months
|
Technical success rate
Time Frame: During the procedure
|
Technical success rate
|
During the procedure
|
Patency rate of branches stents
Time Frame: 12 months
|
Patency rate of branches stents
|
12 months
|
Patency rate of branches stents
Time Frame: 24 months
|
Patency rate of branches stents
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kaichuang Ye, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
December 10, 2022
Study Completion (Estimated)
December 1, 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)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 12, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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