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Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Polymer-based sirolimus-eluting stent (Partner stent )

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Optical Coherence Tomography, Coronary artery disease, Chronic total occlusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

General 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.

Angiographic Inclusion Criteria：

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：

General 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
Creatinine level more than 2.0mg/dL or ESRD.
Severe hepatic dysfunction (more than 3 times normal reference values).
Planned surgery procedure ≤ 6 months post-index procedure.
Known allergy to stainless steel or a history of hypersensitivity to sirolimus or structurally related compounds.
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.
Patient is not clinically appropriate for OCT evaluation in the opinion of the investigator.

Angiographic Exclusion Criteria：

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

Sites / Locations

The second Affiliated Hospital of Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group B: CTO

Group A : Non-CTO

Arm Description

Chronic total occlusion

Non-chronic total occlusion : Fibrous plaque+fibro-calcific plaque + Lipid plaque(<2 quadrants ) Lipid-rich plaque ( ≥2 quadrants )

Outcomes

Primary Outcome Measures

To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.

Secondary Outcome Measures

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.

Late stent malapposition( by OCT and IVUS ).

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.

Full Information

NCT ID

NCT01024179

First Posted

December 1, 2009

Last Updated

December 4, 2009

Sponsor

Harbin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01024179

Brief Title

Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

Official Title

Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Harbin Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Optical Coherence Tomography, Coronary artery disease, Chronic total occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group B: CTO

Arm Type

Active Comparator

Arm Description

Chronic total occlusion

Arm Title

Group A : Non-CTO

Arm Type

Active Comparator

Arm Description

Non-chronic total occlusion : Fibrous plaque+fibro-calcific plaque + Lipid plaque(<2 quadrants ) Lipid-rich plaque ( ≥2 quadrants )

Intervention Type

Device

Intervention Name(s)

Polymer-based sirolimus-eluting stent (Partner stent )

Intervention Description

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

Primary Outcome Measure Information:

Title

To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Relationship between tissue prolapse and initial plaque characteristics

Time Frame

Post-intervention

Title

Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.

Time Frame

6-month

Title

Late stent malapposition( by OCT and IVUS ).

Time Frame

6 months

Title

Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.

Time Frame

12 -month

Title

Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria General 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. Angiographic Inclusion Criteria： 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： General 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 Creatinine level more than 2.0mg/dL or ESRD. Severe hepatic dysfunction (more than 3 times normal reference values). Planned surgery procedure ≤ 6 months post-index procedure. Known allergy to stainless steel or a history of hypersensitivity to sirolimus or structurally related compounds. 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. Patient is not clinically appropriate for OCT evaluation in the opinion of the investigator. Angiographic Exclusion Criteria： Study lesion is ostial in location (within 3.0 mm of vessel origin). Study lesion involving arterial segments with highly tortuous anatomy. Complex lesion morphologies (aorto-ostial, bifurcation needs two stents technique, left main, severe thrombi, heavy calcification).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Yu, MD,PhD

Phone

86-0451-86605180

yubodr@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD.PhD

Organizational Affiliation

The Second Affiliated Hospital of Harbin Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The second Affiliated Hospital of Harbin Medical University

City

Harbin

State/Province

Heilong jiang

ZIP/Postal Code

150081

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD.PhD

Phone

86-0451-86605180

yubodr@163.com

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD,PhD

12. IPD Sharing Statement

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Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

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