What side effects are associated with this type of intervention?

Radial access for cardiac catheterization is associated with a lower risk of bleeding and vascular complications compared to femoral access. Specifically, radial access has been shown to reduce the incidence of major bleeding and vascular complications such as hematomas and pseudoaneurysms. However, it may be associated with a higher risk of radial artery occlusion. On the other hand, femoral access, while more traditional, carries a higher risk of bleeding and vascular complications, including retroperitoneal hemorrhage and access site infections. Both methods require careful management to minimize these risks.

What prior FDA approvals exist?

The FDA has approved various devices and drugs to manage vascular access complications, particularly in the context of cardiac catheterization. Radial and femoral access methods are commonly used, and devices such as paclitaxel-coated balloons and stents have been approved to prevent restenosis and improve patency. Additionally, antithrombotic therapies, including antiplatelet agents like aspirin and anticoagulants such as warfarin and rivaroxaban, have been approved to reduce the risk of thrombotic events following vascular interventions. These treatments aim to minimize complications such as bleeding, thrombosis, and restenosis, thereby improving patient outcomes in procedures involving vascular access.

What other types of research exist?

Promising novel alternatives to radial and femoral access for cardiac catheterization include: 1) Transulnar access, which offers a similar safety profile to radial access but may be beneficial in patients with radial artery occlusion. 2) Distal radial access (snuffbox approach), which has shown potential in reducing bleeding and vascular complications. 3) Transpedal access, primarily used in peripheral interventions, is being explored for coronary procedures due to its minimal invasiveness and lower complication rates. These alternatives are under investigation and may provide viable options for patients in 2024.

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Radial vs. Femoral Access for Cardiac Catheterization Complications (REBIRTH Trial)

N/A

Waitlist Available

Led By Emmanouil Brilakis, MD, PhD

Research Sponsored by Minneapolis Heart Institute Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

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

Must not have

Primary PCI for STEMI

Planned right heart catheterization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluations will occur up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods for inserting a tube into heart blood vessels in patients needing heart checks. One method uses the wrist, and the other uses the groin. The goal is to find out which method is better.

Who is the study for?

Adults over 18 eligible for cardiac catheterization via both radial and femoral access, who consent to participate. Suitable for those needing diagnostic angiography or urgent/elective PCI, but not for patients with recent oral anticoagulant use, peripheral arterial disease affecting access sites, limited life expectancy, certain heart conditions or procedures within the next month.

What is being tested?

This phase IV trial compares two methods of accessing the heart during catheterization: through the wrist (radial access) and upper thigh (femoral access). Participants are randomly assigned to one method; those in the femoral group are further randomized to receive either a smaller (21 gauge) or larger (18 gauge) needle.

What are the potential side effects?

Potential side effects include bleeding at the site where the catheter is inserted, discomfort or pain related to needle size in femoral access cases, possible vascular complications like bruising or clotting at either site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a heart artery exam due to chest pain, possibly with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a procedure to open blocked arteries in my heart due to a severe heart attack.

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I am scheduled for a procedure to check my heart's function.

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I have a condition in my arteries that prevents doctors from accessing my veins.

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I have surgeries planned within 30 days after the initial procedure.

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I have had bypass surgery using arteries from my chest.

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I need heart valve surgery within 30 days after my initial procedure.

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My blood clotting time is higher than normal due to warfarin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluations will occur up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluations will occur up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluations will occur up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Measure of Radiation Dose

Number of participants with Access site crossover

Number of participants with Myocardial Infarction

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: State-of-the-art femoral accessActive Control2 Interventions

Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible).

Group II: Radial accessActive Control1 Intervention

Radial access for cardiac catheterization. Radial access will be performed using ultrasound guidance and a micropuncture needle or catheter-over-needle system, as per the local standard of care.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for vascular access complications include antithrombotic therapy and local drug delivery. Antithrombotic therapy, using antiplatelet agents and systemic anticoagulation, prevents clot formation and maintains vessel patency. Local delivery of drugs like paclitaxel via coated balloons or stents inhibits cell proliferation, reducing the risk of restenosis. These treatments are essential for minimizing complications such as bleeding, thrombosis, and restenosis, thereby enhancing the safety and success of vascular access procedures.

Comparison of Radial and Femoral Percutaneous Coronary Intervention.Radial versus femoral access for primary percutaneous interventions in ST-segment elevation myocardial infarction patients: a meta-analysis of randomized controlled trials.