Non Culprit Lesion Study

May 4, 2020 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • StLuc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Device: the ABSORB:bioresorbable vascular scaffold
Other Names:
  • to compare to optimal medical treatment
Active Comparator: 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
Drug: O.M.T
Other Names:
  • to compare with device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Non Culprit Lesion Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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