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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05134051
Eligibility Criteria:
Inclusion Criteria:
* Angiographic inclusion criteria
* Severely calcified stenoses
* Vessels with RVD between 2.5 - 4.0 mm
* TIMI flow 3
Exclusion Criteria:
* Angiographic exclusion criteria
* Concomitant use of rotational atherectomy
* Severe vessel tortuosity
* Stenosis un-crossable with a balloon/guidewire
* Concomitant conditions
* Contraindication for adenosine administration.
* Hemodynamic or electrical instability.
* Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
* Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2, unless the patient is in renal support therapy.
* Other exclusion criteria
* Unable to provide written informed consent (IC)
* Known pregnancy or breast-feeding at time of inclusion; pre-menopausal women, unless sterilized, must take an effective method of birth control up to 15 weeks after the end of treatment with IP
* Prior myocardial infarction subtended to the PCI target vessel.
* Akinesia or dyskinesia in myocardial segments in the distribution area of the PCI target vessel.
* Severe systolic dysfunction defined as left ventricular ejection fraction \< 35%.
* Patent arterial or venous surgical graft supplying the PCI target vessel.
* Previous TIMI flow \< 1 before guidewire crossing.
* Patient not eligible for drug-eluting stent treatment.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05134051
Study Brief:
Protocol Section:
NCT05134051