Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns (NCT01024179) | Clinical Trial Compass
TerminatedNot Applicable
Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns
Stopped: Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.
China90 participantsStarted 2009-12
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age:18-75Y
✓. Patients with stable angina or acute coronary syndrome considered suitable for coronary revascularization.
✓. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
✓. Significant coronary de novo lesion (\> 70% by visual estimation).
✓. Target lesion is de novo native coronary artery lesion that can be treated with 1-2 stents.
✓. Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion criteria
✕. ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
✕. Previous CABG.
✕. Life expectancy \<12 months due to another medical condition.
✕. Contraindication to antiplatelet therapy
What they're measuring
1
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.