Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography (NeoCover)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Harbin Medical University
Sponsor:
Information provided by (Responsible Party):
Yu Bo, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01875835
First received: June 5, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.

However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.


Condition Intervention Phase
Acute Myocardial Infarction
Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)
Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Harbin Medical University:

Primary Outcome Measures:
  • Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT). [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
    The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.


Secondary Outcome Measures:
  • Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT. [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.

  • Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
    Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 84μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.

  • Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT. [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 84μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.

  • Major adverse cardiovascular events (MACE) [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DES
Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)
Active Comparator: BMS
Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

  Eligibility

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

Inclusion Criteria:

  • Age: 18-75 years
  • Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
  • Length of culprit lesion≤25mm.
  • Vessel size in between 2.5 and 4.0 mm.
  • Signed patient informed consent.

Exclusion Criteria:

  • Prior administration of thrombolytic therapy.
  • Cardiogenic shock.
  • Renal failure (Crea≥2.0mg/dL).
  • Recent major bleeding.
  • Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
  • Left main disease
  • Multi-vessel lesion
  • Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
  • Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
  • No suitable anatomy for OCT scan.
  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: NCT01875835

Contacts
Contact: Bo Yu, MD,PhD 86-045186605180 yubodr@163.com

Locations
China, Heilongjiang
The Second Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Bo Yu, MD,PhD    86-045186605180    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: Yu Bo, The second affiliated hospitai of Harbin medical university, Harbin Medical University
ClinicalTrials.gov Identifier: NCT01875835     History of Changes
Other Study ID Numbers: HMUOCT-STEMI
Study First Received: June 5, 2013
Last Updated: June 25, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Harbin Medical University:
Acute myocardiac infarction
Bare-metal stent
Everolimus-eluting stent
Optical coherence tomography

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014