T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)

Study Overview
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Brief Summary
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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.

Official Title
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Results of T-provisional and Mini Crush Stenting in Patients With Bifurcation Lesions After Chronic Coronary Arteries Occlusions Recanalization: A Prospective Randomized Single-center Study.

Conditions
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Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis

Intervention / Treatment
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* Procedure: T-provisional stenting
* Procedure: Mini-crush stenting
* Procedure: CTO coronary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction). Bifurcation side branch diameter >2 mm in CTO segment, verified by coronary angiography Successful CTO recanalization Signed, documented informed consent prior to admission to the study Exclusion Criteria: Age <18 years or >75 years Left main artery bifurcation lesion Reocclusion CTOs Renal insufficiency (GFR/MDRD <30 ml/min) Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3. Known non-adherence to double anti-platelet therapy (DAPT) LVEF <30% Continuing bleeding Acute coronary syndrome (ST-elevation Myocardial infarction) Anamnesis of previous CABG Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CTO coronary angioplasty +T-provisional stenting<br>Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment. | Procedure: T-provisional stenting<br>* Standard endovascular T-provisional stenting technique<br>Procedure: CTO coronary angioplasty<br>* 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.<br>|
| Experimental: CTO coronary angioplasty + Mini-crush stenting<br>Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment. | Procedure: Mini-crush stenting<br>* Standard endovascular Mini-crush stenting technique<br>Procedure: CTO coronary angioplasty<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Bifurcational lesion, Bifurcational stenting