Coronary Artery Disease Clinical Trial
— LUNAROfficial title:
Lipiscan and Ultrasound Interrogation of Atherosclerotic Coronary Arteries (LUNAR)
Verified date | January 2018 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject is at least 18 years of age; 2. Subject is scheduled for elective, clinically-indicated, invasive coronary angiography; 3. Subject is willing and able to provide informed written consent prior to invasive angiography; 4. Combined NIRS-IVUS is not contra-indicated per the cardiologist performing invasive coronary angiography; and 5. 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. Exclusion Criteria: 1. Subject life expectancy at time of invasive angiography is less than 2 years; 2. Subject is pregnant or suspected to be pregnant; 3. Subject is unable to provide informed consent; 4. 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). 5. Bacteremia or sepsis, 6. Major coagulation system abnormalities, 7. Severe hemodynamic instability or shock, 8. Patients diagnosed with coronary artery spasm, 9. Patients disqualified for CABG surgery, 10. Total occlusion, 11. Patients disqualified for PTCA, 12. Patients who are not suitable for IVUS procedures. |
Country | Name | City | State |
---|---|---|---|
United States | Beaumont Hospital | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
William Beaumont Hospitals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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