Non Culprit Lesion Study

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Completed; Phase 3

Conditions: STEMI

Treatments: Drug: O.M.T; Device: the ABSORB:bioresorbable vascular scaffold

Study type: Interventional

Funder types: Other

Identifiers

NCT02982057

Non Culprit Lesion Study

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Bioresorbable vascular scaffold(BVS)+ OMT

Active Comparator group

Description:

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

Treatment:

Device: the ABSORB:bioresorbable vascular scaffold

OMT

Active Comparator group

Description:

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

Treatment:

Drug: O.M.T