Type B Aortic DissectionLLTEVARNCT03845829
LSA Reconstruction With Laser Fenestration During the TEVAR
A study testing In situ laser assisted fenestration in people with Type B Aortic Dissection, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type B Aortic Dissection
- What is being tested?
- In situ laser assisted fenestration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Life expectancy of < 5 years;
- Patients need open surgery repair for the aortic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Type B Aortic Dissection
- Being tested
- In situ laser assisted fenestration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In situ laser assisted fenestrationProcedure or surgery
In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection
| Study group | Role | What they receive |
|---|---|---|
| Patients with TBAD treated with TEVAR | Experimental | In situ laser assisted fenestration for the left subclavian artery during the TEVAR procedure for TBAD. Receives: Procedure: In situ laser assisted fenestration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days after procedure
Secondary outcomes (4)
Aortic Disease Related Mortality
the incident of death associated with aortic disease.
Measured: 12 months
Incidence of Endoleak Within 12 Months After Procedure
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.
Measured: 12 months
Technical Success Rate During the Procedure
Technical success of successful TEVAR procedure and the in-situ laser-assisted fenestration for LSA revascularization.
Measured: During the procedure
Patency Rate of Branches Stents 12 Months After Procedure
Patency rate (less than 50% in-stent-restenosis) of the subclavian artery stents 12 months after procedure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Jul 2018
- Primary completion10 Dec 2022
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaichuang Ye, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Kaichuang Ye, MD, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845829
- Sponsor's protocol ID
- AAL01
- Acronym
- LLTEVAR
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2019
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41368828
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Subclavian Artery Reconstruction With Laser-assisted Fenestration During the Procedure of Thoracic EndoVascular Aortic Repair for Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT03845829
- Acronym / sponsor ID
- LLTEVAR / AAL01
- Conditions
- Type B Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 18 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with TBAD treated with TEVAR | Experimental | Procedure: In situ laser assisted fenestrationIn situ laser assisted fenestration for the left subclavian artery during the TEVAR procedure for TBAD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (2 listed)
- Life expectancy of < 5 years;
- Patients need open surgery repair for the aortic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In situ laser assisted fenestrationIn situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection | Procedure or surgery | Patients with TBAD treated with TEVAR |
Primary outcome
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.
4 secondary outcomes
Aortic Disease Related Mortality
Time frame: 12 months
Incidence of Endoleak Within 12 Months After Procedure
Time frame: 12 months
Technical Success Rate During the Procedure
Time frame: During the procedure
Patency Rate of Branches Stents 12 Months After Procedure
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41368828Peng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaichuang Ye, MD, PhD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In situ laser assisted fenestration in people with Type B Aortic Dissection, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure (time frame: within 30 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.