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

Meshalkin Research Institute of Pathology of Circulation146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis

Interventions

T-provisional stentingPROCEDURE

Standard endovascular T-provisional stenting technique

Mini-crush stentingPROCEDURE

Standard endovascular Mini-crush stenting technique

CTO coronary angioplastyPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

State Research Institute of CIrculation Pathology

Novosibirsk, Russia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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