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

Primary Purpose

Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
T-provisional stenting
Mini-crush stenting
CTO coronary angioplasty
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Bifurcational lesion, Bifurcational stenting

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • State Research Institute of CIrculation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CTO coronary angioplasty +T-provisional stenting

CTO coronary angioplasty + Mini-crush stenting

Arm Description

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

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

Outcomes

Primary Outcome Measures

Target lesion failure
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)
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
Angiographically estimated main vessel/side branch restenosis. Restenosis is defined as ≥ 50% diameter lumen loss in a target lesion.

Full Information

First Posted
March 9, 2016
Last Updated
May 8, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02708329
Brief Title
T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis
Keywords
Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Bifurcational lesion, Bifurcational stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTO coronary angioplasty +T-provisional stenting
Arm Type
Active Comparator
Arm Description
Coronary angioplasty using T-provisional stenting in patients with bifurcational lesion in Chronic total occlusion segment.
Arm Title
CTO coronary angioplasty + Mini-crush stenting
Arm Type
Experimental
Arm Description
Coronary angioplasty using Mini-crush stenting in patients with bifurcational lesion in Chronic total occlusion segment.
Intervention Type
Procedure
Intervention Name(s)
T-provisional stenting
Intervention Description
Standard endovascular T-provisional stenting technique
Intervention Type
Procedure
Intervention Name(s)
Mini-crush stenting
Intervention Description
Standard endovascular Mini-crush stenting technique
Intervention Type
Procedure
Intervention Name(s)
CTO coronary angioplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Target lesion failure
Description
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 Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular events (MACCE)
Description
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
Title
Restenosis of main vessel/side branch
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

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

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