Clincosm LogoSign in Get a demo

Non Culprit Lesion Study

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT02982057
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
58
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: the ABSORB:bioresorbable vascular scaffold
  • Drug: O.M.T
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of the Treatment of Non- Culprit Lesion After STEMI: Bioresorbable Vascular Scaffold Versus Optimal Medical Therapy (NCLstudy)
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 StLuc Brussels Belgium 1200

    Sponsors and Collaborators

    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    ClinicalTrials.gov Identifier:
    NCT02982057
    Other Study ID Numbers:
    • Non Culprit Lesion Study
    First Posted:
    Dec 5, 2016
    Last Update Posted:
    May 5, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    ST Elevation Myocardial Infarction

    Study Results

    No Results Posted as of May 5, 2020