T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)
NCT ID: NCT02708329
Last Updated: 2016-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CTO coronary angioplasty +T-provisional stenting
Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment.
T-provisional stenting
Standard endovascular T-provisional stenting technique
CTO 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.
CTO coronary angioplasty + Mini-crush stenting
Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment.
Mini-crush stenting
Standard endovascular Mini-crush stenting technique
CTO 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.
Interventions
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T-provisional stenting
Standard endovascular T-provisional stenting technique
Mini-crush stenting
Standard endovascular Mini-crush stenting technique
CTO 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Locations
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State Research Institute of CIrculation Pathology
Novosibirsk, , Russia
Countries
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Other Identifiers
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TvsMC 1.0
Identifier Type: -
Identifier Source: org_study_id
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