Status:
UNKNOWN
Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study
Lead Sponsor:
Medical University of Warsaw
Conditions:
STEMI
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will assess the safety and performance of the Fantom sirolimus eluting bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with unstable lesions and thromboge...
Detailed Description
The aim of the study is to evaluate the acute safety and feasibility of implantation of the sirolimus-eluting bioresorbable Fantom scaffold BVS in the setting of ST segment elevation myocardial infarc...
Eligibility Criteria
Inclusion
- • Electrocardiographic confirmation of acute coronary syndrome with ST segment elevation (according to the 2012 European Society of Cardiology guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation) or high-risk non-ST segment elevation patients in whom urgent reperfusion strategy is applied.
- Symptom onset to balloon inflation time \<12 hours
- Age \>18 years
- The patient's written informed consent has been obtained prior to the procedure.
- Each lesion must meet all the following baseline criteria (prior to pre-dilation):
- De novo lesion in a native coronary artery.
- Visually estimated stenosis of at least 50%.
- Visually estimated RVD ≥2.5 mm and ≤3.5 mm (RVD defined as mean of proximal and distal RVD)
- Lesion length:
- 20 mm by visual estimate for single scaffold implantation
- Each lesion must meet all the following criteria after pre-dilatation:
- Target vessel reference diameter ≤3.5 mm by visual assessment.
- Lesion length:
- 20 mm by visual estimate for single scaffold implantation
Exclusion
- Candidates will be excluded from the trial if ANY of the following exclusion criteria are met:
- A. Clinical
- Cardiogenic shock or pulmonary edema
- Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparins, abciximab, everolimus, or polylactide
- Hypersensitivity to contrast agents
- Concomitant diseases resulting in significantly worse long-term prognosis
- Acute and chronic inflammatory conditions
- Lack of patient consent
- Acute mechanical complications of myocardial infarction
- Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization.
- Fibrinolysis prior to PCI.
- Active bleeding or coagulopathy or patient at chronic anticoagulation therapy
- Life expectancy less then 12 months.
- Patient has a scheduled surgery or another contraindications that may preclude 12-month dual antiplatelet therapy.
- Subject participating in an other trial B. Angiographic
- Significant left main coronary artery stenosis
- Multivessel disease requiring coronary artery bypass grafting (MVD scheduled for percutaneous treatment is not considered as an exclusion criteria).
- Culprit lesion location within a true bifurcation with a large side branch (vessel lumen diameter \>2.0 mm)
- Presence of massive calcifications seen within the vessel contour or identified using intracoronary imaging techniques
- Lesion within a vein bypass graft
- Lesions located within 3 mm from vessel origin
- Target lesion located within previously stented region
- Anatomic location and lesion morphology precluding an optimal effect of percutaneous coronary intervention (PCI) or imaging by OCT in the opinion of the investigator
- Excessive proximal tortuosity
- Vessel diameter \<2.5 mm and \> 3.5 mm
Key Trial Info
Start Date :
June 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03785431
Start Date
June 6 2017
End Date
June 6 2022
Last Update
December 24 2018
Active Locations (1)
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1
1st Department of Cardiology, Medical University of Warsaw
Warsaw, Poland, 02-097