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

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Coronary Artery Disease; Coronary Artery Stenosis; Coronary Atherosclerosis
• Interventions: Procedure: T-provisional stenting; Procedure: Mini-crush stenting; Procedure: CTO coronary angioplasty

• Registration Number: NCT02708329
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-08
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTO coronary angioplasty +T-provisional stenting	T-provisional stenting	Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment.
CTO coronary angioplasty + Mini-crush stenting	CTO coronary angioplasty	Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment.
CTO coronary angioplasty +T-provisional stenting	CTO coronary angioplasty	Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment.
CTO coronary angioplasty + Mini-crush stenting	Mini-crush stenting	Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology; 🇷🇺 Novosibirsk, Russian Federation