Coronary Artery Disease, Coronary Artery Stenosis, Coronary Atherosclerosis, Ischemic Heart Disease
Conditions
Keywords
Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Bifurcational lesion, Bifurcational stenting
Brief summary
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.
Interventions
PROCEDURET-provisional stenting
Standard endovascular T-provisional stenting technique
PROCEDUREMini-crush stenting
Standard endovascular Mini-crush stenting technique
PROCEDURECTO coronary angioplasty
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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | During 1 year after procedure | Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE) | During 1 year after procedure | 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. |
| Restenosis of main vessel/side branch | At 12-month follow-up | Angiographically estimated main vessel/side branch restenosis. Restenosis is defined as ≥ 50% diameter lumen loss in a target lesion. |
Countries
Russia
Outcome results
None listed