NCT03440801Completed
A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI
A Randomized COmparison of LoNg-Term Vascular HealiNg bEtween Biodegradable -Polymer (BP) Versus Durable Polymer (DP) Everolimus Eluting Stents in Acute ST-Elevation Myocardial InfarCTion
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 struts at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 240 (actual)
- First submitted
- 12 Feb 2018
- Start date
- 3 Jul 2017
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- Tokorozawa Heart Center
- Diseases
- Coronary artery disease
- NCT number
- NCT03440801
What you commit to
- Study type: Interventional
- Participants enrolled: 240
- From 3 Jul 2017 to the primary completion date, 30 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
Other illness
- Mechanical complications of acute myocardial infarction
- Acute myocardial infarction secondary to stent thrombosis or restenosis
- History of bleeding diathesis or known coagulopathy
- Cancer under active treatment (chemotherapy)
Lab values
- Chronic kidey disease (Creatinine - Clearance \< 30ml/min)
Age
- Female ofchildbearing potential (age \< 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
- Noncardiac comorbid conditions are present with life expectancy \<3years or that may result in protocol noncompliance
- Age \>90 years
Other
- 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
- Use of oral anticoagulation
- LV-function at index procedure \<=20%
- Hemodynamic instability following primary PCI
- OCT technically not feasible (severe calcification, tortuosity)
Who the study is looking for
- 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
Age in the registry: 20 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tokorozawa Heart Center Coordinator of this site? Confirm its status | Tokorozawa | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.