Non Culprit Lesion Study

Phase 3CompletedNCT02982057

Cliniques universitaires Saint-Luc- Université Catholique de Louvain50 enrolled

Overview

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

Objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with BVS could facilitate the stabilization process into the atherosclerotic plaque with modifications of plaque morphology, especially the lipid content which is considered as one of the main factor leading to recurrent MACE after an ACS. The interaction between the polymer Platform and the vessel wall, the effect of the everolimus on neointima growth and cellular response into the media could reduce the inflammatory process into the vulnerable plaque could be different Under OMT and BVS implantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

STEMI

Interventions

the ABSORB:bioresorbable vascular scaffoldDEVICE

O.M.TDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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%

Locations (1)

StLuc

Brussels, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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