Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT01740895
Eligibility Criteria:
Inclusion Criteria:
* \- Patient must be \> 18 and \< 85 years of age
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and/or percutaneous coronary intervention
* Coronary artery disease with at least 1 or more visually assessed coronary stenoses (\>40% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
* Stable angina or acute coronary syndromes (non-culprit vessels only and outside of primary intervention during acute myocardial infarction)
Exclusion Criteria:
* \- Known contraindication to adenosine administration
* Implanted temporary or permanent artificial pacemakers, Left Bundle Branch Block (LBBB), 1st and 2nd degree AV Block
* STEMI or non STEMI within 48 hours of procedure
* Any contraindications for FFR interrogation or percutaneous coronary intervention (PCI) as determined by the investigator
* Severe vessel tortuosity and/or severe calcification by angiogram
* Significant valvular pathology (moderate or severe AS/AR/MS/MR)
* Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
* Weight \>200kg (441 lbs.)
* Hemodynamic instability at the time of intervention (heart rate\<50 beats per minute, systolic blood pressure \<90mmHg) balloon pump
* Significant hepatic disease, renal disease, lung disease (pulmonary chronic pulmonary obstructive disease) and/or malignant disease with unfavorable prognosis or presenting with abnormal serum laboratory values that the physician believes is clinically significant
* Contraindication to antithrombotic regimen or anticoagulation therapy
* History of or known reaction or sensitivity to contrast agent and is unable to be pre-medicated
* Left main stenosis, tandem stenosis separated by more than 5 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis), or total occlusions
* Known Left ventricular ejection fraction (LVEF) \<30%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01740895
Study Brief:
Protocol Section:
NCT01740895