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

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Stenosis

Treatments: Procedure: Mini-crush stenting; Procedure: CTO coronary angioplasty; Procedure: T-provisional stenting

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02708329

TvsMC 1.0

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

CTO coronary angioplasty +T-provisional stenting

Active Comparator group

Description:

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

Treatment:

Procedure: T-provisional stenting

Procedure: CTO coronary angioplasty

CTO coronary angioplasty + Mini-crush stenting

Experimental group

Description:

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

Treatment:

Procedure: Mini-crush stenting

Procedure: CTO coronary angioplasty