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

Acute Myocardial Infarction Clinical Trial

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Official title:

Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01875835
• Other study ID #: HMUOCT-STEMI
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 5, 2013
• Last updated: December 19, 2016
• Start date: June 2013
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)

• Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).	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.	3-month	Yes
Secondary	Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.	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.	12-month	Yes
Secondary	Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.	Strut malapposition is defined as struts detached from the vessel wall > 108µm for EES and > 101µm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.	3-month	Yes
Secondary	Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.	Strut malapposition is defined as struts detached from the vessel wall > 108µm for EES and > 101µm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.	12-month	Yes
Secondary	Major adverse cardiovascular events (MACE)		12-month	Yes