Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

NCT ID: NCT03172845

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-27
• Study Completion Date: 2019-07-30

Brief Summary

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

Detailed 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.

Conditions

Coronary Bifurcation Lesions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Vulnerable plaque

Thin-cap fibro atheroma (TCFA) was defined as a lipid-rich plaque with the thinnest fibrous cap thickness\<65um. Plaque rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque. Plaque erosion is characterized by luminal thrombus and absence of the endothelium or without evidence of fibrous cap disruption. Fibro calcific plaque contains OCT evidence of fibrous tissue along with calcium that appears as a signal-poor or heterogeneous region with a sharply delineated border which is applied to larger calcifications. 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. 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.

Group Type: EXPERIMENTAL

percutaneous coronary intervention

Intervention Type: PROCEDURE

percutaneous coronary intervention with drug-eluting stent implantation.

Without any vulnerable plaqueStable plaque

patient with bifurcation lesion undergoing baseline coronary angiography and baseline OCT.

Group Type: ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type: PROCEDURE

percutaneous coronary intervention with drug-eluting stent implantation.

Interventions

percutaneous coronary intervention

percutaneous coronary intervention with drug-eluting stent implantation.

Intervention Type: PROCEDURE

Other Intervention Names

PCI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shaoliang Chen

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaoliang Chen, MD

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NFH20170423

Identifier Type: -

Identifier Source: org_study_id