NCT02699671

Brief Summary

The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug eluting stents) DES.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

March 1, 2016

Last Update Submit

September 6, 2021

Conditions

Arterial Occlusive DiseasesCardiovascular DiseasesCoronary Artery Disease

Keywords

Bioresorbable Vascular ScaffoldRoutine Clinical PracticeAngioplasty, Transluminal, Percutaneous CoronaryCoronary Artery Diseasedrug eluting stentacute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Composite event

    The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

    1year

Secondary Outcomes (10)

  • All death

    5years

  • Cardiac death

    5years

  • Myocardial infarction

    5years

  • Composite event of death or myocardial infarction

    5years

  • Composite event of cardiac death or myocardial infarction

    5years

  • +5 more secondary outcomes

Study Arms (1)

acute myocardial infarction

Device: Bioresorbable Vascular Scaffold

Interventions

Bioresorbable Vascular ScaffoldDEVICE
acute myocardial infarction

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute myocardial infarction patients with Bioresorbable Vascular Scaffold

You may qualify if:

  • Age 19 and more
  • Acute myocardial infarction
  • Intervention with Bioresorbable Vascular Scaffold
  • Agreed with written informed consent form

You may not qualify if:

  • Bypass graft surgery (CABG) recommended
  • Lesion with previous bypass graft surgery (CABG)
  • Severe calcification and/or severe tortuosity
  • Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
  • Life expectancy of 1year and under
  • Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
  • Cardiac shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Arterial Occlusive DiseasesCardiovascular DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 4, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations

KR(1)