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

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT02708329

Collaborator

(none)

146

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis	Procedure: T-provisional stenting Procedure: Mini-crush stenting Procedure: CTO coronary angioplasty	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: CTO coronary angioplasty +T-provisional stenting

Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment.

Procedure: T-provisional stenting

Standard endovascular T-provisional stenting technique

Procedure: 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.

Experimental: CTO coronary angioplasty + Mini-crush stenting

Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment.

Procedure: Mini-crush stenting

Standard endovascular Mini-crush stenting technique

Procedure: CTO coronary angioplasty

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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