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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT02743156
Eligibility Criteria:
Inclusion Criteria:
* Age over 18 years
* Coronary artery disease referred for percutaneous intervention, with stent implantation, of one or more epicardial vessel.
----\>All target lesions must be amenable to IVUS imaging, as judged by an experienced interventionalist (lesions not assessable by IVUS at baseline but which are judged to the assessable at any time during the procedure are eligible).
* Baseline calculated creatinine clearance \< 60 ml/min/1.73 m2 or baseline creatinine \> 1.5 mg/dl
* Ability to sign informed consent and comply with all study procedures
Exclusion Criteria:
* Use of \> 50 ml (single-lesion PCI) or \> 70 ml (multi-lesion PCI) of iodinated agents \< 72 hours (this restriction includes the contrast used during the diagnostic phase of ad hoc PCI).
* Planned use of iodinated contrast within the next 72 hours after the index procedure
* Use of other nephrotoxic agents \< 7 days
* Known allergy to contrast agents
* Unstable or unknown renal function prior to PCI.
* Prior PCI of the target lesions
* Patients requiring additional surgery (cardiac or non cardiac) within 72 hours after the index procedure
* Non cardiac co-morbidities with life expectancy less than 1 year
* Other investigational drug or device studies that have not reached their primary endpoint
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02743156
Study Brief:
Protocol Section:
NCT02743156