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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT02933892
Eligibility Criteria:
Inclusion Criteria:
1. Patients scheduled to undergo non-emergent cardiac catheterization at University Medical Center Hospital, Lubbock, TX from January 2016 to January 2018. Emergent cardiac catheterizations will be defined as a catheterization scheduled \< 24 hours from a cardiac event.
2. Patients willing to be randomized to TFA or TRA procedure.
3. Patients signed and dated the informed consent agreeing to participate in the study.
4. Patients with chronic kidney disease, defined as eGFR = 15-59mL/min defined by the MDRD formula. (eGFR is a standard of care measurement for all patients undergoing coronary intervention.).
5. Patients ages 18-88 years old.
Exclusion Criteria:
1. Patients who have previously undergone a coronary artery bypass graft procedure.
2. Patients with prior catheterization within the last 5 years.
3. Women who are pregnant or expect to become pregnant. Pregnancy tests for women of childbearing potential (WOCHP) will be performed as standard of care.
4. Patients with a history of cardiogenic shock.
5. Children (under the age of 18).
6. Medical, geographical, or social factors making study participation impractical, i.e. documented noncompliance, unable to return for follow-ups and lab draws, etc.
7. A positive Allen's Test on the right radial artery.
8. Any condition preventing TRA or TFA access.
9. Contrast used within the previous 3 weeks.
10. Allergy to contrast dye.
11. Inability to successfully access the artery randomized to use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT02933892
Study Brief:
Protocol Section:
NCT02933892