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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT05077657
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
* The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Exclusion Criteria:
* Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
* Active bleeding
* Incapacity to access safely femoral artery or femoral vein
* Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
* Anemia (Hgb \<9 g/dL), thrombocytopenia (Plt \<50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
* Active infection not controlled with antibiotic therapy
* Currently pregnant or women of child-bearing potential without documented negative pregnancy test
* Estimated life expectancy \< 24 hours
* Patient is in cardiogenic shock at the time of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05077657
Study Brief:
Protocol Section:
NCT05077657