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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with TBAD treated with TEVAR | Experimental | In situ laser assisted fenestration for the left subclavian artery during the TEVAR procedure for TBAD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 30 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Disease Related Mortality | the incident of death associated with aortic disease. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaichuang Ye, MD, PhD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaichuang Ye | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41368828 | Derived | 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. |
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No patient was excluded in this study when enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Complicated and High-risk 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: In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary safety endpoint was 84% (84/100), with 19 events occurring in 16 patients. | Posted | Count of Participants | Participants | within 30 days after procedure |
|
with 30 days after procedure.
The major adverse events included mortality, stroke, MI, rupture, paraplegia, type Ia endoleak, major bleeding, AKI, limb ischemia, bowel ischemia, retrograde dissection, SINE, access site complications and unplanned reinterventions, which was referred to intervention for major adverse events, included surgical repair for ascending aortic pathologies, coronary artery stenting, embolism for type Ia endoleak, additional proximal or distal aortic stents deployment, intervention for access sites.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Complicated and High-risk 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: In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaichuang Ye | Department of Vascular Surgery, Shanghai Ninth People's Hospital | +86-021-2327166 | ykaichuang@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2020 | Feb 16, 2025 | Prot_SAP_000.pdf |
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| 12 months |
| Technical Success Rate During the Procedure | Technical success of successful TEVAR procedure and the in-situ laser-assisted fenestration for LSA revascularization. | 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. | 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| smoking | Count of Participants | Participants |
|
| BMI >25 | Count of Participants | Participants |
|
| Comorbidity | Number | participants |
|
| Time from onset of symptoms to procedure | Count of Participants | Participants |
|
| Aortic dissection acuity | Count of Participants | Participants |
|
|
|
| Secondary | Aortic Disease Related Mortality | the incident of death associated with aortic disease. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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. | all types of endoleak during the follow up. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Technical Success Rate During the Procedure | Technical success of successful TEVAR procedure and the in-situ laser-assisted fenestration for LSA revascularization. | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 2 |
| 100 |
| 16 |
| 100 |
| 0 |
| 100 |
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Mesenteric ischemia | Gastrointestinal disorders | Systematic Assessment |
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| Ia endoleak | Vascular disorders | Systematic Assessment |
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| Spinal cord ischemia | Nervous system disorders | Systematic Assessment |
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| Retrograde dissection | Vascular disorders | Systematic Assessment |
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| Retrograde IMH | Vascular disorders | Systematic Assessment |
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| Access site pseudoaneurysm | Vascular disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Ia endoleak |
|