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Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

NCT ID: NCT01024179

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group B: CTO

Chronic total occlusion

Group Type ACTIVE_COMPARATOR

Polymer-based sirolimus-eluting stent (Partner stent )

Intervention Type DEVICE

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

Group A : Non-CTO

Non-chronic total occlusion :

1. Fibrous plaque+fibro-calcific plaque + Lipid plaque(\<2 quadrants )
2. Lipid-rich plaque ( ≥2 quadrants )

Group Type ACTIVE_COMPARATOR

Polymer-based sirolimus-eluting stent (Partner stent )

Intervention Type DEVICE

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

Interventions

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Polymer-based sirolimus-eluting stent (Partner stent )

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

Intervention Type DEVICE

Eligibility Criteria

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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.


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

1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
2. Previous CABG.
3. Life expectancy \<12 months due to another medical condition.
4. Contraindication to antiplatelet therapy
5. Creatinine level more than 2.0mg/dL or ESRD.
6. Severe hepatic dysfunction (more than 3 times normal reference values).
7. Planned surgery procedure ≤ 6 months post-index procedure.
8. Known allergy to stainless steel or a history of hypersensitivity to sirolimus or structurally related compounds.
9. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
10. Patient is not clinically appropriate for OCT evaluation in the opinion of the investigator.


1. Study lesion is ostial in location (within 3.0 mm of vessel origin).
2. Study lesion involving arterial segments with highly tortuous anatomy.
3. Complex lesion morphologies (aorto-ostial, bifurcation needs two stents technique, left main, severe thrombi, heavy calcification).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yu Bo

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Yu, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Locations

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The second Affiliated Hospital of Harbin Medical University

Harbin, Heilong Jiang, China

Site Status

Countries

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China

Other Identifiers

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HMUOCT-PLAQUE

Identifier Type: -

Identifier Source: org_study_id