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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT04928118
Eligibility Criteria:
Inclusion Criteria:
Impella-protected PCI selection criteria according to Virginia Commonwealth University (VCU) Complex PCI Program
* Left ventricular ejection fraction (LVEF) ≤35% and ≥1 complexity feature
* LVEF ≤45% and estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m2 and ≥1 complexity feature
* LVEF ≤45% and eGFR 31-45 ml/min/1.73 m2 and ≥2 complexity features
Complexity features
* Planned treatment of ≥2 vessels
* Left main PCI
* Bifurcation intervention with 2-stent strategy
* Planned use of atherectomy (rotational, orbital, laser)
* Chronic total occlusion PCI
* PCI on last remaining vessel
* LVEDP \>18 mmHg
* Cardiac index \<2.0 l/min/m2 or pulmonary artery O2 saturation \<55%
Exclusion Criteria:-
* Pregnancy or lactation
* Presence of non-MRI compatible implanted medical device
* Known absolute contraindication to Impella insertion, e.g. severe peripheral arterial disease, left ventricular thrombus, aortic mechanical prosthesis, or severe aortic valve stenosis
* Chronic hemodialysis before the index procedure
* Status post-renal transplant
* Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04928118
Study Brief:
Protocol Section:
NCT04928118