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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00831116
Other study ID # 0111
Secondary ID
Status Completed
Phase N/A
First received January 27, 2009
Last updated June 8, 2017
Start date February 2009
Est. completion date April 2017

Study information

Verified date June 2017
Source InfraReDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment.


Recruitment information / eligibility

Status Completed
Enrollment 2067
Est. completion date April 2017
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject is at least 18 years of age.

- Subject is scheduled for elective coronary catheterization.

- LipiScan CIS, LipiScan IVUS Imaging System, or TVC Imaging System use is not contra-indicated.

- At least one chemogram from a native coronary artery is available for submission to the registry.

- Able to read, understand and sign the informed consent.

Exclusion Criteria:

- Subject is pregnant or nursing.

- Subject life expectancy is less than 2 years at time of index catheterization.

- All submitted chemograms are obtained with the LipiScan, LipiScan IVUS, or TVC(R) Imaging Catheter positioned within a coronary artery bypass graft.

- Unable to give informed consent

Study Design


Intervention

Device:
Intravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.

Locations

Country Name City State
United States Piedmont Hospital Atlanta Georgia
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Lahey Clinic Burlington Massachusetts
United States Medical University of South Carolina Hospital Charleston South Carolina
United States Veterans Affairs, North Texas Health Care Systems Dallas Texas
United States University of Florida, Gainesville Gainesville Florida
United States Mercy Gilbert Medical Center Gilbert Arizona
United States Pinnacle Heart & Vascular Institute Harrisburg Pennsylvania
United States University of California, Los Angeles Medical Center Los Angeles California
United States Columbia Universtiy Medical Center New York New York
United States Mount Sinai School of Medicine New York New York
United States University of California Irvine Medical Center Orange California
United States Mayo Clinic Rochester Minnesota
United States Crittenton Shelton Heart Center: Rochester Hills Michigan
United States William Beaumont Hospital Royal Oak Michigan
United States Saint Louis University Hospital Saint Louis Missouri
United States San Francisco Veterans Affairs Medical Center San Francisco California
United States Scottsdale Healthcare Scottsdale Arizona
United States Swedish Medical Center Seattle Washington
United States Washington Adventist Hospital Takoma Park Maryland
United States Pepin Heart Hospital Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
InfraReDx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population after completion of the study - during data analysis
Secondary Identification of associations that LCP or the Lipid Core Burden Index (LCBI) may have with atherosclerosis appearance, progression, regression, and/or cardiac event Upto 2 years post procedure(baseline)
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