Non Culprit Lesion Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02982057

Enrollment

Registered

2016-12-05

Start date

2015-01-31

Completion date

2019-11-01

Last updated

2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI

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.

Interventions

DEVICEthe ABSORB:bioresorbable vascular scaffold

DRUGO.M.T

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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%

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026