Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque

Withdrawn before enrolling

Conditions studied: Coronary Artery Disease, Atherosclerosis

In brief

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.

Key facts

Study ID

NCT01747525

Run by

Corewell Health East

People needed

0

Starts

2011-10-01

Expected to finish

2013-10-01

Last updated by the study team

2018-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.