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 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT02000661
Eligibility Criteria:
Inclusion Criteria:
1. Subjects with stable coronary artery disease or recent acute coronary syndrome (ACS). Subjects who present with ST elevation myocardial infarction (STEMI) are allowed to be included after 5 days from initial presentation.
2. At least one obstructive coronary lesion is present with vessel reference diameter ≥2.5 mm and diameter stenosis ≥50% by visual estimate. Lesions must be technically suitable for the FFR procedure and angioplasty with stent placement.
3. Physician will classify all target lesions and need for FFR before randomization, and there is a plan to perform a non-emergent PCI.
4. Subject is ≥18 years old, with signed informed consent.
Exclusion Criteria:
1. Expected non-cardiac longevity \< 2 years.
2. Planned treatment with CABG.
3. Planned treatment with medical therapy.
4. Left main disease \> 50% diameter stenosis based on visual estimate.
5. Safety issues:
1. Unstable hemodynamics or serious arrhythmias during procedure;
2. Ongoing ischemic chest pain;
3. High grade AV block (unless pacemaker);
4. Allergic to adenosine.
6. When FFR is clearly not needed:
1. Target vessel with slow flow (\< TIMI-3);
2. Single vessel disease with ≥90% stenosis;
3. Single vessel disease with ≥80% stenosis and documented ischemia on functional imaging test;
4. In acute coronary syndrome, ≥70 stenosis identified as culprit.
7. When FFR is clearly needed for all target lesions: as declared by the operator.
8. Technical difficulty:
1. Severe vessel tortuosity;
2. Severe coronary calcification;
3. Anticipate difficult wiring;
4. Aorto-ostial lesion (ok for IV adenosine is used as the hyperemic agent).
9. Interpretation difficulty:
1. Target vessel acting as a major collateral donor;
2. When RA pressure very high;
3. STEMI within past 5 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02000661
Study Brief:
Protocol Section:
NCT02000661