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Official title Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
ClinicalTrials.gov ID: NCT04077762
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Peripheral arterial disease prohibiting vascular access
- Presence of bilateral internal mammary artery coronary bypass grafts
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Decatur, Georgia, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Jacksonville, Florida, United States; Decatur, Georgia, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.