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

May 8, 2016 updated by: Meshalkin Research Institute of Pathology of Circulation

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • State Research Institute of Circulation Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: 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.
Procedure: Mini-crush stenting
Standard endovascular Mini-crush stenting technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure
Time Frame: 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.
During 1 year after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: 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.
During 1 year after procedure
Restenosis of main vessel/side branch
Time Frame: At 12-month follow-up
Angiographically estimated main vessel/side branch restenosis. Restenosis is defined as ≥ 50% diameter lumen loss in a target lesion.
At 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 8, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TvsMC 1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on T-provisional stenting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe