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Completed

NCT Number: NCT02982057

Non Culprit Lesion Study

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

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Key information

Conditions

STEMI Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

StLuc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

the ABSORB:bioresorbable vascular scaffold

Device

Other names: to compare to optimal medical treatment

O.M.T

Drug

Other names: to compare with device

Primary outcomes

  1. measure size of the vulnerable plaque

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

A Randomized Trial of the Treatment of Non- Culprit Lesion After STEMI: Bioresorbable Vascular Scaffold Versus Optimal Medical Therapy (NCLstudy)

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2016
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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