RecruitingNot ApplicableNCT04077762

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

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

Sponsor

Minneapolis Heart Institute Foundation

Enrollment

3,266 participants

Start Date

Nov 15, 2019

Study Type

INTERVENTIONAL

Conditions

Patient Satisfaction Vascular Access Complication

Summary

This is a phase IV, prospective, open label, randomized-controlled study that will 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria12

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

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Interventions

PROCEDURERadial Access

Radial Access

PROCEDUREState-of-the-art femoral access with 18 gauge needle

State-of-the-art femoral access with 18 gauge needle

PROCEDUREState-of-the-art femoral access with 21 gauge needle

State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.