Status:
COMPLETED
A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI
Lead Sponsor:
Tokorozawa Heart Center
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
Conditions:
STEMI - ST Elevation Myocardial Infarction
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief Summary
This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing such as the frequency of malapposed and uncovered stent...
Detailed Description
DES use has significantly improved clinical outcomes as compared with bare metal stents (BMS), primarily through a notable reduction in the risk of repeat revascularisation. However, durable polymer D...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Primary PCI within 24 hours of symptom onset
- ST-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguuoius anterior leads
- Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents
Exclusion
- Female ofchildbearing potential (age \< 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
- Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material
- Inability to understand and provide informed consent
- Currently participating in another trial before reaching first endpoint
- Mechanical complications of acute myocardial infarction
- Acute myocardial infarction secondary to stent thrombosis or restenosis
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- Noncardiac comorbid conditions are present with life expectancy \<3years or that may result in protocol noncompliance
- History of bleeding diathesis or known coagulopathy
- Use of oral anticoagulation
- Age \>90 years
- LV-function at index procedure \<=20%
- Cancer under active treatment (chemotherapy)
- Hemodynamic instability following primary PCI
- Chronic kidey disease (Creatinine - Clearance \< 30ml/min)
- OCT technically not feasible (severe calcification, tortuosity)
Key Trial Info
Start Date :
July 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03440801
Start Date
July 3 2017
End Date
September 1 2024
Last Update
September 8 2025
Active Locations (1)
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1
Tokorozawa Heart Center
Tokorozawa, Japan, 3591142