Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

Coronary Bifurcation Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172845
• Other study ID #: NFH20170423
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: July 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Bifurcation Lesions

Intervention

Procedure:
• percutaneous coronary intervention
percutaneous coronary intervention with drug-eluting stent implantation.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (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.	Documentation of baseline OCT
Secondary	Major Adverse Cardiovascular Events (MACE)	MACE was included myocardial infarction, cardiac death, and target lesion revascularization.	0 to 12 months
Secondary	Stent Thrombosis	Stent thrombosis was defined according to the Academic Research Consortium definition.	0 to 12 months
Secondary	Thin-cap fibroatheroma	Thin-cap fibroatheroma was defined as a lipid-rich plaque with the thinnest fibrous cap thickness < 65 µm.	0 to 12 months
Secondary	Calcified nodule	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.	0 to 12 months
Secondary	Plaque erosion	Plaque erosion is characterized by luminal thrombus and absence of the endothelium, without evidence of fibrous cap disruption.	0 to 12 months
Secondary	Plaque rupture	Rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque.	0 to 12 months
Secondary	Thrombus	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.	0 to 12 months