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Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

NCT01024179 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-12-02

No results posted yet for this study

Summary

Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.

Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months. IVUS will also be performed to evaluate the tissue protrusion, malapposition, vessel remodeling at the same time points.

Conditions

Interventions

DEVICE

Polymer-based sirolimus-eluting stent (Partner stent )

Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • Bo Yu, MD.PhD · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024179 on ClinicalTrials.gov