NCT01747525

Brief Summary

The primary objective of this study is to characterize coronary artery blockages as determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.

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 Oct 2011

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withdrawn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

October 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

December 7, 2012

Last Update Submit

January 6, 2018

Conditions

Coronary Artery DiseaseAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque

    The primary objective of this study is to characterize coronary artery blockages as determined by the Lipiscan combined NIRS-IVUS catheter in multiple coronary arteries.

    1 year

Study Arms (1)

NIRS/IVUS of coronary artery

All patients will have an epicardial coronary artery stenosis of intermediate severity (\>50% to \<70% stenosis) (stenosis ≥20% - ≤70%) by invasive angiography in whom IVUS is planned to further clinical evaluation of lesion severity; or a severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment.

Device: NIRS/IVUS of coronary artery

Interventions

NIRS/IVUS of coronary arteryDEVICE

Evaluation of coronary plaque by NIRS/IVUS.

Also known as: Infraredx
NIRS/IVUS of coronary artery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients presenting to Beaumont Hospital for elective invasive coronary angioplasty and possible percutaneous intervention.

You may qualify if:

  • Subject is at least 18 years of age;
  • Subject is scheduled for elective, clinically-indicated, invasive coronary angiography;
  • Subject is willing and able to provide informed written consent prior to invasive angiography;
  • Combined NIRS-IVUS is not contra-indicated per the cardiologist performing invasive coronary angiography; and
  • Patient has either: (a) An epicardial coronary artery stenosis of intermediate severity (\>50% to \<70% stenosis)by invasive angiography in whom IVUS is planned to further evaluate lesion severity; or (b) A severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment.

You may not qualify if:

  • Subject life expectancy at time of invasive angiography is less than 2 years;
  • Subject is pregnant or suspected to be pregnant;
  • Subject is unable to provide informed consent;
  • Any factor deemed by the treating cardiologist to put the patient at increased risk of participating in the protocol (i.e. coronary artery anatomy is not suitable for traditional IVUS secondary to severe tortuousity or excessive calcification).
  • Bacteremia or sepsis,
  • Major coagulation system abnormalities,
  • Severe hemodynamic instability or shock,
  • Patients diagnosed with coronary artery spasm,
  • Patients disqualified for CABG surgery,
  • Total occlusion,
  • Patients disqualified for PTCA,
  • Patients who are not suitable for IVUS procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Simon R Dixon, MBChB

    Corewell Health East

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Cardiovascular Medicine, Co-Director of Cardiovascular Research

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

US(1)