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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT04079192
Eligibility Criteria:
Inclusion Criteria:
* Patients presenting with in-stent restenosis (ISR) and clinical symptoms of ischemia and/or (i) evidence of ischemia on non-invasive testing or (ii) hemodynamically relevant lesion defined by FFR ≤ 0.80 or iFR ≤ 0.89 or \> 90% stenosis.
* Patient presenting with a lesion that can be fully covered with one DCB length. - Patients can have up to two index lesions with ISR, which can both be treated and evaluated.
* Patient has provided written informed consent
* Age ≥ 18 years.
* Patient is willing and able to comply with the study procedures and follow-up.
Exclusion Criteria:
* Patient presents with a ST-elevation myocardial infarction (STEMI) or had an acute MI within 48 hours prior to presentation (according to the universal definition of myocardial infarction).
* Patient with acute cardiac decompensation or acute cardiogenic shock
* Documented left ventricular ejection fraction (LVEF) ≤ 30%
* Patient with impaired renal function (glomerular filtration rate \< 80 mL/min/1.73 m2).
* More than 2 epicardial vessels requiring revascularization
* Significant left main stenosis (by visual estimation) or an ISR located in the left main (LM).
* Patient has an ISR lesion that cannot be covered with one DCB length.
* Patient has an ISR in the target segment in a stent of a smaller diameter than 2.5mm.
* Severe calcification that might prevent a sufficient expansion of the DCB, if not pre-treated with rotablation or a shockwave application device.
* Known hypersensitivity or contraindication to biolimus, paclitaxcel, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
* Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
* Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
* Anticipated difficulties to complete the angiographic follow-up study.
* Patient with a life expectancy of less than 12 months.
* Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04079192
Study Brief:
Protocol Section:
NCT04079192