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The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB strategy | Experimental |
| |
| DES strategy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel DCB | Device | Drug-coated balloon is a new kind of coronary interventional device. The balloon coated with anti-cell proliferation drugs (paclitaxel, etc.) is sent to the stenosis site. The balloon is closely adhered to the vascular wall during the expansion, and the drug is rapidly and evenly coated on the disaffected vessels.In recent years, DCB has gradually become an alternative for the treatment of in-stent restenosis (ISR), small vessel disease (SVD) and bifurcation disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Target lesion failure (TLF) | Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization. | 12 months |
| Number of Participants with net adverse clinical cardiovascular events (NACCE) | Net adverse clinical cardiovascular events, defined as cardiac death, clinically driven target vessel myocardial infarction, target lesion revascularization and major bleeding (BARC type 2, 3, 5 bleeding) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | According to CAG, the residual stenosis of the main branch is less than 30% and the residual stenosis of the side branch is less than 50%. The blood flow is of TIMI III as well | 1-2 days |
| Number of Participants with Target lesion failure (TLF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yida Tang, Prof | Contact | 13901010211 | tang_yida@163.com | |
| Yupeng Wang, Prof | Contact | wangyp007@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| DES | Device | Provisional T technique is the preferred method for the treatment of bifurcation lesions with the existing stent.According to the 2018 European Guidelines on revascularization and the consensus group of the European Bifurcation Club (EBC), Provisional T technique is still the first choice for the treatment of Bifurcation, despite the problems related to side branches. |
|
Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization |
| 1/6/24/36 month |
| Number of Participants with Target lesion revascularization (TLR) | Target lesion revascularization, defined as clinically indicated percutaneous or surgical revascularization of the index lesion during follow-up, like using stent, balloon, coronary atherectomy, or CABG | 1/6/12/24/36 month |
| Number of Participants with Target vessel revascularization (TVR) | Target vessel revascularization, defined as clinically indicated percutaneous or surgical revascularization of the target vessel during follow-up, like using stent, balloon, coronary atherectomy, or CABG | 1/6/12/24/36 month |
| Clinical procedure time | The used time in the clinical procedure | during the procedure |
| DAPT using time | The using time of DAPT | 1/6/12/24/36 month |
| Number of Participants with Bleeding events（BARC2, 3, and 5） | Definite, probable, or possible thrombus in the device defined by ARC: Acute thrombus, subacute thrombus, late thrombus, and very late thrombus | 1/6/12/24/36 month |
| Number of Participants with ARC defines stent thrombosis | The identification and possibility of stent thrombosis were included in the time ranges of acute, subacute, late, and late | 1/6/12/24/36 month |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |