Non Culprit Lesion Study

STEMI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982057
• Other study ID #: Non Culprit Lesion Study
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: November 1, 2019

Study information

• Verified date: May 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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%

Related Conditions & MeSH terms

• ST Elevation Myocardial Infarction
• STEMI

Intervention

Device:
• the ABSORB:bioresorbable vascular scaffold

Drug:
• O.M.T

Locations

Country	Name	City	State
Belgium	StLuc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years