An interventional study of T-provisional stenting and Mini-crush stenting in Ischemic Heart Disease, Coronary Atherosclerosis and Coronary Artery Disease, sponsored by Meshalkin Research Institute of Pathology of Circulation. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-10.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Not applicable, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 146 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment.
Procedure: T-provisional stenting · Procedure: CTO coronary angioplasty
Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment.
Procedure: Mini-crush stenting · Procedure: CTO coronary angioplasty
Standard endovascular T-provisional stenting technique
Standard endovascular Mini-crush stenting technique
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.
Target lesion failure
Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
Time frame: During 1 year after procedure
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.
Time frame: 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.
Time frame: At 12-month follow-up
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Meshalkin Research Institute of Pathology of Circulation