Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2015-01-31
2019-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bioresorbable vascular scaffold(BVS)+ OMT
hypothesis: scaffolding a non culprit coronary plaque with BVS could facilitate the stabilization process into the atherosclerotic plaque with modification of plaque morphology.
Intervention:Device
the ABSORB:bioresorbable vascular scaffold
OMT
Comparator with ONLY optimal medical treatment (OMT): the aim of the study is to compare the evolution of non culprit lesions after treatment by BVS versus Optimal Medical Therapy at 2 years follow- up.
Intervention: medical treatment
O.M.T
Interventions
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the ABSORB:bioresorbable vascular scaffold
O.M.T
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* patient not able to sign an IC
* cardiogenic shock
* left main disease
* GFR\<30ml/min/m2
* previous CABG
* LVEF\<35%
18 Years
80 Years
ALL
No
Sponsors
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Locations
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StLuc
Brussels, , Belgium
Countries
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Other Identifiers
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Non Culprit Lesion Study
Identifier Type: -
Identifier Source: org_study_id
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