Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: Polymer-based sirolimus-eluting stent (Partner stent )

• Registration Number: NCT01024179
• Lead Sponsor: Harbin Medical University

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group B: CTO	Polymer-based sirolimus-eluting stent (Partner stent )	Chronic total occlusion
Group A : Non-CTO	Polymer-based sirolimus-eluting stent (Partner stent )	Non-chronic total occlusion : 1. Fibrous plaque+fibro-calcific plaque + Lipid plaque(\<2 quadrants ) 2. Lipid-rich plaque ( ≥2 quadrants )

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilong Jiang, China