Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Harbin Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01024179
First received: December 1, 2009
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Polymer-based sirolimus-eluting stent (Partner stent )
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Harbin Medical University:

Primary Outcome Measures:
  • To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relationship between tissue prolapse and initial plaque characteristics [ Time Frame: Post-intervention ] [ Designated as safety issue: Yes ]
  • Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions. [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]
  • Late stent malapposition( by OCT and IVUS ). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation. [ Time Frame: 12 -month ] [ Designated as safety issue: Yes ]
  • Comparison of the differences in stent surface coverage between CTO and non- CTO lesions. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 :

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024179

Contacts
Contact: Bo Yu, MD,PhD 86-0451-86605180 yubodr@163.com

Locations
China, Heilong jiang
The second Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilong jiang, China, 150081
Contact: Bo Yu, MD.PhD    86-0451-86605180    yubodr@163.com   
Principal Investigator: Bo Yu, MD,PhD         
Sponsors and Collaborators
Harbin Medical University
Investigators
Principal Investigator: Bo Yu, MD.PhD The Second Affiliated Hospital of Harbin Medical University
  More Information

No publications provided

Responsible Party: Bo Yu, Department of Cardiology of The Second Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT01024179     History of Changes
Other Study ID Numbers: HMUOCT-PLAQUE
Study First Received: December 1, 2009
Last Updated: December 4, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Harbin Medical University:
Optical Coherence Tomography
Coronary artery disease
Chronic total occlusion

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014