Non Culprit Lesion Study

NCT ID: NCT02982057

Last Updated: 2020-05-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-11-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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STEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

the ABSORB:bioresorbable vascular scaffold

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

O.M.T

Intervention Type DRUG

Interventions

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the ABSORB:bioresorbable vascular scaffold

Intervention Type DEVICE

O.M.T

Intervention Type DRUG

Other Intervention Names

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to compare to optimal medical treatment to compare with device

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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StLuc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Non Culprit Lesion Study

Identifier Type: -

Identifier Source: org_study_id

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