Type B Aortic Dissection
Conditions
Brief 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
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).
Interventions
PROCEDUREIn situ laser assisted fenestration
In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Disease Related Mortality | 12 months | the incident of death associated with aortic disease. |
| Incidence of Endoleak Within 12 Months After Procedure | 12 months | 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. |
| Technical Success Rate During the Procedure | During the procedure | Technical success of successful TEVAR procedure and the in-situ laser-assisted fenestration for LSA revascularization. |
| Patency Rate of Branches Stents 12 Months After Procedure | 12 months | Patency rate (less than 50% in-stent-restenosis) of the subclavian artery stents 12 months after procedure. |
Countries
China
Participant flow
Pre-assignment details
No patient was excluded in this study when enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Patients With TBAD Treated With TEVAR |
|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 12.4 |
| Aortic dissection acuity Complicated | 18 Participants |
| Aortic dissection acuity High risk | 82 Participants |
| BMI >25 | 29 Participants |
| Comorbidity Acute limb ischemia | 6 participants |
| Comorbidity Acute mesenteric ischemia | 3 participants |
| Comorbidity Cerebrovascular disease | 7 participants |
| Comorbidity Chronic kidney disease | 6 participants |
| Comorbidity Chronic obstructive pulmonary disease | 11 participants |
| Comorbidity Chronic renal artery occlusion | 2 participants |
| Comorbidity Congestive heart failure | 1 participants |
| Comorbidity Diabetes | 8 participants |
| Comorbidity Hypertension | 90 participants |
| Comorbidity Ischemia heart disease | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 100 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China Fengcheng Hospital, Fengxian, Shanghai | 6 Participants |
| Region of Enrollment China Shanghai ninth people's hospital, Shanghai Jiaotong University School of Medicine | 48 Participants |
| Region of Enrollment China Shanghai third people's hospital, Shanghai Jiaotong University School of Medicine | 27 Participants |
| Region of Enrollment China Taizhou Municipal hospital, Taizhou, Zhejiang | 13 Participants |
| Region of Enrollment China Zhoupu Hospital, Pudong, Shanghai | 6 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 81 Participants |
| smoking | 38 Participants |
| Time from onset of symptoms to procedure Acute stage (24h-14d) | 52 Participants |
| Time from onset of symptoms to procedure Hyperacute stage (<24h) | 26 Participants |
| Time from onset of symptoms to procedure Subacute stage (>14d) | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 16 / 100 |
Outcome results
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.
Time frame: within 30 days after procedure
Population: The primary safety endpoint was 84% (84/100), with 19 events occurring in 16 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure | 84 Participants |
Secondary
Aortic Disease Related Mortality
the incident of death associated with aortic disease.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Aortic Disease Related Mortality | 0 Participants |
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.
Time frame: 12 months
Population: all types of endoleak during the follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Incidence of Endoleak Within 12 Months After Procedure | R endoleak | 2 Participants |
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Incidence of Endoleak Within 12 Months After Procedure | II endoleak | 2 Participants |
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Incidence of Endoleak Within 12 Months After Procedure | Ib endoleak | 4 Participants |
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Incidence of Endoleak Within 12 Months After Procedure | Ia endoleak | 1 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Patency Rate of Branches Stents 12 Months After Procedure | 98 Participants |
Secondary
Technical Success Rate During the Procedure
Technical success of successful TEVAR procedure and the in-situ laser-assisted fenestration for LSA revascularization.
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Complicated and High-risk TBAD Treated With TEVAR | Technical Success Rate During the Procedure | 98 Participants |