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Completed

NCT Number: NCT02708329

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

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.

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Stenosis Coronary Atherosclerosis Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-provisional stenting

Procedure

Standard endovascular T-provisional stenting technique

Mini-crush stenting

Procedure

Standard endovascular Mini-crush stenting technique

CTO coronary angioplasty

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 15, 2016
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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