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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT04862559
Eligibility Criteria:
Inclusion Criteria:
* Adult aged 25-80
* Patient understands and has signed the study informed consent form.
* Patient is a suitable candidate for non-emergent, coronary angioplasty
* Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0.
* Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
* CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
* CTO lesion is suitable for antegrade approach.
* Left ventricle ejection fraction \> 25%
* Body Mass Index (BMI) \< 40
Exclusion Criteria:
* Patient unable to give informed consent.
* Patient is participating in another study with any investigational drug or device.
* Patient is known or suspected not to tolerate the contrast agent.
* Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO.
* Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
* Appearance of a fresh thrombus or intraluminal filling defects.
* Recent major cerebrovascular event (stroke or TIA within 30 days)
* Significant anemia (hemoglobin \< 8.0 mg / dl)
* Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
* Recent myocardial infarction (MI) (within the past two weeks)
* Unwillingness or inability to comply with any protocol requirements
* Pregnancy or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
80 Years
Study:
NCT04862559
Study Brief:
Protocol Section:
NCT04862559