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Non Culprit Lesion Study

Primary Purpose

STEMI

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
the ABSORB:bioresorbable vascular scaffold
O.M.T
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

  • StLuc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bioresorbable vascular scaffold(BVS)+ OMT

OMT

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 7, 2016
Last Updated
May 4, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02982057
Brief Title
Non Culprit Lesion Study
Official Title
A Randomized Trial of the Treatment of Non- Culprit Lesion After STEMI: Bioresorbable Vascular Scaffold Versus Optimal Medical Therapy (NCLstudy)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioresorbable vascular scaffold(BVS)+ OMT
Arm Type
Active Comparator
Arm 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
Arm Title
OMT
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
the ABSORB:bioresorbable vascular scaffold
Other Intervention Name(s)
to compare to optimal medical treatment
Intervention Type
Drug
Intervention Name(s)
O.M.T
Other Intervention Name(s)
to compare with device
Primary Outcome Measure Information:
Title
measure size of the vulnerable plaque
Description
the size of the vulnerable plaque measured by angio FU at 2 years with an investigation of the same segment than at baseline.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Facility Information:
Facility Name
StLuc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Non Culprit Lesion Study

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