Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)

Overview

About this study

The purpose of this study is to compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Age 18 years and older

- Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI

- Has provided informed consent and agrees to participate

- Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access

Exclusion Criteria:

- Primary PCI for STEMI

- Planned right heart catheterization

- Valvular heart disease requiring valve surgery within 30 days after the index procedure

- Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access
if a dialysis graft is present in one)

- Peripheral arterial disease prohibiting vascular access

- Presence of bilateral internal mammary artery coronary bypass grafts

- International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e., warfarin) Receipt of oral factor Xa or IIa inhibitors ≤ 24 h before procedure

- Planned staged PCI within 30 days after index procedure.

- Any planned surgeries within 30 days after index procedure

- Planned dual arterial access (for example for chronic total occlusion PCI)

- Coexisting conditions that limit life expectancy to less than 30 days

- Positive pregnancy test

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/21/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Abdallah El Sabbagh, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Abdallah El Sabbagh, M.D.

Closed for enrollment

More information

Publications

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