A randomized comparison of acute thrombogenecity and long-term vascular healing between biodegradable-polymer (BP) versus durable polymer (DP) everolimus-eluting stents in acute ST-elevation myocardial infarctio

Not Applicable

Recruiting

• Conditions: Acute myocardial infarction

• Registration Number: JPRN-UMIN000027082
• Lead Sponsor: Tokorozawa Heart Center Clinical trial unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-20
• Study Completion: 2022-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

1.Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. 2.Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material 3.Inability to understand and provide informed consent 4.Currently participating in another trial before reaching first endpoint 5.Mechanical complications of acute myocardial infarction 6.Acute myocardial infarction secondary to stent thrombosis or restenosis 7.Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period 8.Noncardiac comorbid conditions are present with life expectancy <3years or that may result in protocol noncompliance 9.History of bleeding diathesis or known coagulopathy 10.Use of oral anticoagulation 11.Age >=90 years 12.LV-function at index procedure <=20% 13.Cancer under active treatment (chemotherapy) 14.Hemodynamic instability following primary PCI 15.Chronic kidey disease (Creatinine - Clearance < 30ml/min) 16.OCT technically not feasible (severe calcification, tortuosity)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of neoatherosclerosis lesion which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of >= 1 mm at 3 years

Secondary Outcome Measures

Name	Time	Method
The athero-thrombotic material area (tissue protorusion + isolated intraluminal detect) within the stent strut after primary PCI