Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Polymer-based sirolimus-eluting stent (Partner stent )

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilong Jiang
    • Harbin, Heilong Jiang, China, 150081
      • The Second Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.

Angiographic Exclusion Criteria：

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B: CTO; Chronic total occlusion	Device: Polymer-based sirolimus-eluting stent (Partner stent ); Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery
Active Comparator: Group A : Non-CTO; Non-chronic total occlusion : Fibrous plaque+fibro-calcific plaque + Lipid plaque(<2 quadrants ); Lipid-rich plaque ( ≥2 quadrants )	Device: Polymer-based sirolimus-eluting stent (Partner stent ); Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.	To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between tissue prolapse and initial plaque characteristics	Relationship between tissue prolapse and initial plaque characteristics	Post-intervention
Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.	Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.	6-month
Late stent malapposition( by OCT and IVUS ).	Late stent malapposition( by OCT and IVUS ).	6 months
Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.	Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.	12 -month
Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.	Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.	12 months

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Investigators: Principal Investigator: Bo Yu, MD.PhD, The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimated): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Coronary artery disease; Optical Coherence Tomography; Chronic total occlusion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Sirolimus
• Other Study ID Numbers: HMUOCT-PLAQUE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No