NCT02982057

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

4.8 years

First QC Date

November 7, 2016

Last Update Submit

May 4, 2020

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Bioresorbable vascular scaffold(BVS)+ OMT

ACTIVE COMPARATOR

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

OMT

ACTIVE COMPARATOR

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

Interventions

the ABSORB:bioresorbable vascular scaffoldDEVICE
Also known as: to compare to optimal medical treatment
Bioresorbable vascular scaffold(BVS)+ OMT
O.M.TDRUG
Also known as: to compare with device
OMT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • non compliant profile
  • patient not able to sign an IC
  • cardiogenic shock
  • left main disease
  • GFR\<30ml/min/m2
  • previous CABG
  • LVEF\<35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StLuc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

December 5, 2016

Study Start

January 1, 2015

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Locations

BE(1)