STEMI Clinical Trial
Official title:
A Randomized Trial of the Treatment of Non- Culprit Lesion After STEMI: Bioresorbable Vascular Scaffold Versus Optimal Medical Therapy (NCLstudy)
Verified date | May 2020 |
Source | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the present study is to compare the evolution of non culprit lesions after treatment by BVS versus optimal medical therapy at 2-years follow- up
Status | Completed |
Enrollment | 50 |
Est. completion date | November 1, 2019 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - STEMI and multivessel ASCL - Successful and uneventful primary PCI - Non culprit lesion > /= 2.5mm RVD suitable for investigation by FFR - At least one segment of minimum 10 mm length containing a non culprit lesion Exclusion Criteria: - non compliant profile - patient not able to sign an IC - cardiogenic shock - left main disease - GFR<30ml/min/m2 - previous CABG - LVEF<35% |
Country | Name | City | State |
---|---|---|---|
Belgium | StLuc | Brussels |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | measure size of the vulnerable plaque | the size of the vulnerable plaque measured by angio FU at 2 years with an investigation of the same segment than at baseline. | 2 years |
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