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

ConditionsPatient SatisfactionVascular Access Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinneapolis Heart Institute Foundation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radial Access

    Procedure/Surgery

    Radial Access

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

    Procedure/Surgery

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

  • State-of-the-art femoral access with 21 gauge needle

    Procedure/Surgery

    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.

Treatment groups

3,266 Participants
are divided into 2 treatment groups
Group A: Radial accessActive comparator 1 intervention
Group B: State-of-the-art femoral accessActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)

Time frame
Evaluations will occur up to 30 days

Secondary outcomes

1

Total number of BARC type 2, 3, or 5 bleeding events

Time frame
Evaluations will occur up to 30 days
2

Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;

Time frame
Evaluations will occur up to 30 days
3

Number of participants with Radial artery occlusion

Time frame
Evaluations will occur up to 30 days
4

Number of participants with Access site crossover

The inability to complete the procedure from the assigned arterial access site, requiring conversion from radial to femoral access or vice versa for procedure completion

Time frame
Measured during procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minneapolis Heart Institute Foundation

Lead sponsor

Source ClinicalTrials.gov
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