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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04698902
Eligibility Criteria:
Inclusion Criteria:
* Patients \>18 years of age
* Patients with an indication for PCI (ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of \>50% de novo severely calcified coronary stenosis that requires IVL treatment.
Exclusion Criteria:
* Patients unwilling or unable to sign informed consent for the procedure
* Patients with severe peripheral vascular disease limiting vascular access to the extent that it is unsafe to perform the procedure
* Patients with severe renal dysfunction (eGFR \<15mls/min and not receiving dialysis)
* Treatment of vessels \< 2.5mm diameter which are not amenable to IVL treatment or OCT assessment.
* Treatment of lesions located very distally in the coronary vessel where the OCT catheter may not reach.
* Inability to cross the lesion with the OCT catheter due to very severe stenosis or severe vessel tortuosity.
* Ostial left main stem or right coronary artery lesions which may be difficult to visualise by OCT
* Patients requiring concomitant use of rotational or orbital atherectomy of LASER.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04698902
Study Brief:
Protocol Section:
NCT04698902