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

June 5, 2013
June 25, 2013
June 2013
April 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01875835 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography
Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)
  • Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)
  • Active Comparator: DES
    Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
    Intervention: 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)
    Intervention: Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Bo Yu, MD,PhD 86-045186605180 yubodr@163.com
China
 
NCT01875835
HMUOCT-STEMI
No
Yu Bo, Harbin Medical University
Harbin Medical University
Not Provided
Principal Investigator: Bo Yu, MD,PhD The Second Affiliated Hospital of Harbin Medical University
Harbin Medical University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP