Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation Acute Myocardial Infarction with two different everolimus-eluting stents: Randomized controlled trial between biodegradable polymer and durable polymer stent

JRCT ID: jRCTs022180024

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: ST elevation acute myocardial infarction (STEMI)
• Date of first enrollment: 08/11/2018
• Target sample size: 120
• Study type: Interventional
• Intervention(s): revascularization of culprit lesions of ST-elevation myocardial infarction with either bioabsorbable polymer-based everolimus-eluting stent or durable polymer-based everolimus-eluting stent (1:1 randomization)

Outcome(s)

• Primary Outcome: Strut coverage rate evaluated by optical coherence tomography 2 weeks after stent implantation

Secondary Outcome

Evaluation by optical coherence tomography at post-procedure, 2 weeks, 1 year
1) strut coverage rate
2) maximum area of in-stent thrombus
3) mal-apposition rates of struts
4) minimal limen area

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1)Patients with ST-elevation acute myocardial infarction
2)Patients with existence of coronary culprit lesions that should be treated with drug-eluting stents
3)Patients with planned cardiac catheterization procedure after 2 weeks

Exclude criteria

1)Hemodynamically shock
2)Culprit lesion of left main coronary artery
3)Chronic renal failure with serum creatinine levels = or > 2.0mg/dl(including hemodialysis)
4)Cancer patients with life prognosis shorter than 2 years or scheduled surgery within 3 months

Related Information

• Primary Sponsor: MORINO YOSHIHIRO
• Source(s) of Monetary Support: Boston Scientific KK