Non Culprit Lesion Study

Phase 3

Completed

• Conditions: STEMI
• Interventions: Drug: O.M.T

• Registration Number: NCT02982057
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-04
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT	O.M.T	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

Primary Outcome Measures

Name	Time	Method
measure size of the vulnerable plaque	2 years	the size of the vulnerable plaque measured by angio FU at 2 years with an investigation of the same segment than at baseline.

Trial Locations

Locations (1)

StLuc; 🇧🇪 Brussels, Belgium