Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

NCT03172845 | Completed DMC

• 1 other identifier: NFH20170423
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Bifurcation Lesions

Keywords

coronary bifurcation lesion; optical coherence tomography; vulnerable plaque

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Major Adverse Cardiovascular Events (MACE)

  0 to 12 months

• Stent Thrombosis

  0 to 12 months

• Thin-cap fibroatheroma

  0 to 12 months

• Calcified nodule

  0 to 12 months

• Plaque erosion

  0 to 12 months

Study Arms (2)

Vulnerable plaque

EXPERIMENTAL

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.

Procedure: percutaneous coronary intervention

Without any vulnerable plaqueStable plaque

ACTIVE COMPARATOR

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

Procedure: percutaneous coronary intervention

Interventions

percutaneous coronary intervention PROCEDURE

percutaneous coronary intervention with drug-eluting stent implantation.

Also known as: PCI

Vulnerable plaque; Without any vulnerable plaqueStable plaque

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Shaoliang Chen, MD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: June 1, 2017
• Study Start: June 27, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)