NCT02981134

Brief Summary

The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
5 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

November 30, 2016

Last Update Submit

July 19, 2021

Conditions

Coronary Disease

Keywords

bioabsorbable scaffoldcomputed tomography

Outcome Measures

Primary Outcomes (1)

  • Computed tomographic scan parameters

    Computed tomographic scan parameters predicting clinical outcomes

    3 years

Secondary Outcomes (6)

  • Restenosis

    1 year

  • Thrombosis

    1 year

  • Lumen loss

    1 year

  • Positive predictive value

    3 years

  • Clinical outcomes

    3 years

  • +1 more secondary outcomes

Study Arms (1)

bioabsorbable scaffold

Patients with BVS(bioabsorbable scaffold) for coronary stenosis

Procedure: Computed tomographic scan

Interventions

Computed tomographic scanPROCEDURE

after 1year of BVS implantation, computed tomographic scan will be performed

bioabsorbable scaffold

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with Bioresobable Vascular Scaffold for coronary disease

You may qualify if:

  • Patients treated withBioresobable Vascular Scaffold for coronary disease

You may not qualify if:

  • History of allergy to contrast
  • Serum Creatinine \> 2.0 mg/dl
  • Severe arrhythmia
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor, Department of Cardiology, Heart Institute, University of Ulsan College of Medicine

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 5, 2016

Study Start

December 1, 2021

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

KR(1)