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Completed

NCT Number: NCT03172845

Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion.

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Key information

Conditions

Coronary Bifurcation Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

This is a prospective registry study in which patient with bifurcation lesion undergoing baseline coronary angiography, baseline OCT and percutaneous coronary intervention will be studied. OCT is used to assess the prevalence of vulnerable plaque, its location at bifurcation lesions and compare vulnerable plaque related major adverse cardiovascular events (MACE) during one-year follow-up in bifurcation lesions between patients with vulnerable plaque and those without. Relationship between endothelial shear stress and vulnerable plaque. Relationship between bifurcation angle and vulnerable plaque.

Group A: presence of vulnerable plaque at the bifurcation Group B: absence of vulnerable plaque at the bifurcation Documentation of immediate post stent OCT and 12 months follow up angiography with OCT will be performed. Immediate post stent OCT to assess successful stent implantation and after 12 months follow up to document year major adverse cardiovascular events (MACE) included myocardial infraction, cardiac death and clinically driven target lesion revascularization, stent thrombosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients ≥ 18 years old
  • Patients with ischemic heart disease who are considered for coronary revascularization with PCI
  • True coronary bifurcation lesion Medina 1.1.1, 0.1.1, 1.0.1 (stenosis> 50% by visual estimation) treated by drug-eluting stent
  • Reference vessel diameter of main vessel >= 2.5mm and side branch >=2.0 mm by visual estimation

Exclusion criteria

  • Saphenous vein grafts
  • In-stent restenotic lesions
  • Thombus-containing lesions
  • Patient who had Myocardial infarction with in less than one month
  • Patent who had bifurcation lesion dilation with balloon
  • Contraindication or hypersensitivity to anti-platelet agents or contrast media
  • Creatinine level ≥ 2.0 mg/dL
  • Severe hepatic dysfunction (3 times normal reference values)
  • Hemodynamic unstable patients
  • Inability of OCT devise to cross the lesion into distal vessel
  • Pregnant women or women with potential childbearing
  • Inability to understand or read the informed content

Treatment and study plan

Percutaneous coronary intervention

Procedure

percutaneous coronary intervention with drug-eluting stent implantation.

Other names: PCI

Primary outcomes

  1. The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT)

    Time frame: Documentation of baseline OCT

    Vulnerable plaque was considered when presence of Thin-cap fibro atheroma (TCFA), Lipid-rich plaque (vulnerable), Plaque rupture, Plaque erosion, thrombus and calcified nodule.

Secondary outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Time frame: 0 to 12 months

    MACE was included myocardial infarction, cardiac death, and target lesion revascularization.

  2. Stent Thrombosis

    Time frame: 0 to 12 months

    Stent thrombosis was defined according to the Academic Research Consortium definition.

  3. Thin-cap fibroatheroma

    Time frame: 0 to 12 months

    Thin-cap fibroatheroma was defined as a lipid-rich plaque with the thinnest fibrous cap thickness < 65 µm.

  4. Calcified nodule

    Time frame: 0 to 12 months

    Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion.

  5. Plaque erosion

    Time frame: 0 to 12 months

    Plaque erosion is characterized by luminal thrombus and absence of the endothelium, without evidence of fibrous cap disruption.

  6. Plaque rupture

    Time frame: 0 to 12 months

    Rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque.

  7. Thrombus

    Time frame: 0 to 12 months

    Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Prevalence of Vulnerable Plaque Its Location and Clinical Significance in Bifurcation Lesions Detected by Optical Coherence Tomography.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 1, 2017
Registry last updated
Jul 30, 2019

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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