Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01024179
• Other study ID #: HMUOCT-PLAQUE
• Status: Recruiting
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: December 4, 2009
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2009
• Source: Harbin Medical University
• Contact: Bo Yu, MD,PhD
• Phone: 86-0451-86605180
• Email: yubodr[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Polymer-based sirolimus-eluting stent (Partner stent )
Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery

Locations

Country	Name	City	State
China	The second Affiliated Hospital of Harbin Medical University	Harbin	Heilong jiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.		6 months	Yes
Secondary	Relationship between tissue prolapse and initial plaque characteristics		Post-intervention	Yes
Secondary	Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.		6-month	Yes
Secondary	Late stent malapposition( by OCT and IVUS ).		6 months	Yes
Secondary	Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.		12 -month	Yes
Secondary	Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.		12 months	Yes