Status:
TERMINATED
Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
Lead Sponsor:
Columbia University
Conditions:
Coronary; Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 p...
Detailed Description
Fractional flow reserve (FFR) measurement by under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated i...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Patient provides signed written informed consent before any study-specific procedure.
- Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
- Angiographically 40%-90% stenosis present in at least one native coronary artery.
- Undergoing physiological assessment for standard clinical or diagnostic indications
Exclusion
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Left main stenosis
- Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease.
- Saphenous vein graft, chronic total occlusion
- Haemodynamic instability at the time of intervention (heart rate\<50 beats per minute, systolic blood pressure \<90mmHg), balloon pump
- Currently participating in another clinical study that interferes with study results.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
- High degree A-V block, sinus node disease.
- Asthma/Chronic obstructive pulmonary disease (COPD) with active wheeze
- Known hypersensitivity to adenosine
- ST-Elevation Myocardial Infarction (STEMI) within 48 hours.
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03461705
Start Date
October 20 2017
End Date
August 2 2018
Last Update
February 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University
New York, New York, United States, 10032