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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT07001332
Eligibility Criteria:
Inclusion Criteria:
1. Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
2. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
3. Participant signed the informed consent.
Exclusion Criteria:
1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
2. Prior stroke with any permanent, significant (mRS\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
4. Evidence of left ventricular thrombus.
5. Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
6. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
8. Patient on dialysis.
9. Known or suspected coagulopathy OR abnormal coagulation parameters.
10. Known allergy, sensitivity or intolerance to nickel.
11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
13. Any non-cardiac condition with a life expectancy \< 12 months.
14. Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
15. Pregnancy or breast-feeding.
16. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures.
17. Subject belongs to a vulnerable population.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT07001332
Study Brief:
Protocol Section:
NCT07001332