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The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTO coronary angioplasty +T-provisional stenting | Active Comparator | Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment. |
|
| CTO coronary angioplasty + Mini-crush stenting | Experimental | Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-provisional stenting | Procedure | Standard endovascular T-provisional stenting technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. | During 1 year after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE) | Major adverse cardiac and cerebrovascular events (MACCE) including: including: All-cause mortality, Myocardial infarction, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization. | During 1 year after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of CIrculation Pathology | Novosibirsk | 630055 | Russia |
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| Mini-crush stenting | Procedure | Standard endovascular Mini-crush stenting technique |
|
| CTO coronary angioplasty | Procedure | A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months. |
|
| Restenosis of main vessel/side branch | Angiographically estimated main vessel/side branch restenosis. Restenosis is defined as ≥ 50% diameter lumen loss in a target lesion. | At 12-month follow-up |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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