Coronary Artery Disease
Conditions
Keywords
Optical Coherence Tomography, Coronary artery disease, Chronic total occlusion
Brief 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.
Detailed description
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.
Interventions
DEVICEPolymer-based sirolimus-eluting stent (Partner stent )
Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery
Sponsors
Harbin Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria： 1. Age:18-75Y 2. Patients with stable angina or acute coronary syndrome considered suitable for coronary revascularization. 3. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent. Angiographic Inclusion Criteria： 1. Significant coronary de novo lesion (\> 70% by visual estimation). 2. Target lesion is de novo native coronary artery lesion that can be treated with 1-2 stents. 3. Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion criteria
： General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation. | 6 months | To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between tissue prolapse and initial plaque characteristics | Post-intervention | Relationship between tissue prolapse and initial plaque characteristics |
| Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions. | 6-month | Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions. |
| Late stent malapposition( by OCT and IVUS ). | 6 months | Late stent malapposition( by OCT and IVUS ). |
| Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation. | 12 -month | Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation. |
| Comparison of the differences in stent surface coverage between CTO and non- CTO lesions. | 12 months | Comparison of the differences in stent surface coverage between CTO and non- CTO lesions. |
Countries
China
Outcome results
None listed