Clinical trial NCT01875835: Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography
Official title: Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardiac infarction
Bare-metal stent
Everolimus-eluting stent
Optical coherence tomography
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
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).
timeFrame: 3-month
Secondary outcomes:
measure: Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
timeFrame: 12-month
measure: Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
timeFrame: 3-month
measure: Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
timeFrame: 12-month
measure: Major adverse cardiovascular events (MACE)
timeFrame: 12-month
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: