Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

NCT01024179 | Terminated

• 1 other identifier: HMUOCT-PLAQUE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Optical Coherence Tomography; Coronary artery disease; Chronic total occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  6-month

• Late stent malapposition( by OCT and IVUS ).

  6 months

• 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.

  12 months

Study Arms (2)

Group B: CTO

ACTIVE COMPARATOR

Chronic total occlusion

Device: Polymer-based sirolimus-eluting stent (Partner stent )

Group A : Non-CTO

ACTIVE COMPARATOR

Non-chronic total occlusion : 1. Fibrous plaque+fibro-calcific plaque + Lipid plaque(\<2 quadrants ) 2. Lipid-rich plaque ( ≥2 quadrants )

Device: Polymer-based sirolimus-eluting stent (Partner stent )

Interventions

Polymer-based sirolimus-eluting stent (Partner stent ) DEVICE

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

Group A : Non-CTO; Group B: CTO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The second Affiliated Hospital of Harbin Medical University

Harbin, Heilong Jiang, 150081, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bo Yu, MD.PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (1)