NCT02330861

Brief Summary

Subjects are patients who are planned to do percutaneous coronary intervention for coronary stenosis in the left circumflex artery without other stenosis in the left ascending artery and the right coronary artery, or a patient with normal coronary artery. Immediately after coronary angiography or percutaneous coronary intervention, the investigators will evaluate for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary pressure and flow velocity with Combowire in each coronary segment. Also, they will assess coronary morphology by View It in each coronary segment.

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 2014

Typical duration for not_applicable

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withdrawn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

Study Start

First participant enrolled

December 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 2, 2018

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

December 24, 2014

Last Update Submit

August 1, 2018

Conditions

Coronary Stenosis

Keywords

Coronary Circulation

Outcome Measures

Primary Outcomes (1)

  • Wave intensity

    Immediately after coronary angiography or percutaneous coronary intervention

Secondary Outcomes (3)

  • Coronary pressure

    Immediately after coronary angiography or percutaneous coronary intervention

  • Flow velocity

    Immediately after coronary angiography or percutaneous coronary intervention

  • Vessel diameter

    Immediately after coronary angiography or percutaneous coronary intervention

Study Arms (1)

Normal coronary artery

OTHER
Device: combowire and IVUS

Interventions

combowire and IVUSDEVICE
Normal coronary artery

Eligibility Criteria

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

You may qualify if:

  • A patient who are planned to do percutaneous coronary intervention for stenosis in the left circumflex artery without any lesions in other coronary arteries
  • Or a patient who is performed coronary angiography without significant stenosis lesion in 3-coronary vessel

You may not qualify if:

  • A patient with coronary stenosis with LAD
  • Hemodialysis
  • Acute coronary syndrome
  • Congestive heart failure
  • A patient with shock vitals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyogo College of Medicine

Nishinomiya, 6638501, Japan

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Relationship between pressure and flow velocity on coronary physiology

Study Record Dates

First Submitted

December 24, 2014

First Posted

January 5, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

August 2, 2018

Record last verified: 2017-02

Locations

JP(1)