Patient SatisfactionREBIRTHNCT04077762
Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
A study testing Radial Access, State-of-the-art femoral access with 18 gauge needle and State-of-the-art femoral access with 21 gauge needle in people with Patient Satisfaction and Vascular Access Complication, run by Minneapolis Heart Institute Foundation at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Vascular Access Complication
- What is being tested?
- Radial Access, State-of-the-art femoral access with 18 gauge needle and State-of-the-art femoral access with 21 gauge needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,266 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Nov 2019to 19 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Olga Mastrodemos contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, 30033
Nikki Leslie, RN, 404-321-6111, nikki.leslie@va.gov
Kreton Mavromatis, MD
- Not yet recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Michelle Butcher, RN, 313-916-7614, mbutche1@hfhs.org
Khaldoon Alaswad, MD
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Federico Simon, 904-953-4205, Simon.FedericoRey@mayo.edu
Abdallah El Sabbagh, MD
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Bavana Rangan, BDS, MPH, CCRP, 612-863-3852, bavana.rangan@allina.com
- Recruiting
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Rebecca Straily, RN, 405-608-1287, rstraily@okheart.com
Mazen Abu-Fadel, MD
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Jeffrey Zimmet, MD, PhD, 415-221-4810, jeffrey.zimmet@va.gov
Kendrick Shunk, MD, PhD
About this study
Official title: Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)
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.
- Conditions
- Patient Satisfaction, Vascular Access Complication
- Being tested
- Radial Access, State-of-the-art femoral access with 18 gauge needle, State-of-the-art femoral access with 21 gauge needle
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial AccessProcedure or surgery
Radial Access
State-of-the-art femoral access with 18 gauge needleProcedure or surgery
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 21 gauge needleProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Radial access | Active comparator | 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. Receives: Procedure: Radial Access |
| State-of-the-art femoral access | Active comparator | 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). Receives: Procedure: State-of-the-art femoral access with 18 gauge needle; Procedure: State-of-the-art femoral access with 21 gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
Measured: Evaluations will occur up to 30 days
Secondary outcomes (17)
Total number of BARC type 2, 3, or 5 bleeding events
Measured: Evaluations will occur up to 30 days
Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;
Measured: Evaluations will occur up to 30 days
Number of participants with Radial artery occlusion
Measured: Evaluations will occur up to 30 days
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
Measured: Measured during procedure
Number of other vascular access related complications
Measured: Evaluations will occur up to 30 days
Total procedure time
The time from administration of local anesthesia to the time of removal of all interventional equipment
Measured: Measured during procedure
Time to ambulation
Measured: Measured up to 24 hours after procedure completion
Number of all cause death and cardiac death
Measured: Evaluations will occur up to 30 days
Number of participants with Myocardial Infarction
The 4th Universal Definition of myocardial infarction
Measured: Evaluations will occur up to 30 days
Number of participants with Stroke
Measured: Evaluations will occur up to 30 days
Number of participants with unplanned coronary revascularization
Measured: Evaluations will occur up to 30 days
Measure of Radiation Dose
Both air kerma and dose air product
Measured: Measured during procedure
Fluoroscopy Time
Measured: Measured during procedure
Contrast volume
Measured: Measured during procedure
Number of participants with Procedural Success
Using the National Cardiovascular Disease Registry (NCDR) definition
Measured: Evaluations will occur up to 30 days
Duration of hospital stay and frequency of same day discharge
Measured: Evaluations will occur up to 30 days
Patient Preference Survey: Radial Vs Femoral Access
Participants will be asked which access site they would have preferred to have their procedure
Measured: Evaluations will occur up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start15 Nov 2019
- Primary completion19 Aug 2027 (estimated)
- Study completion19 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanouil Brilakis, MD, PhD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077762
- Sponsor's protocol ID
- REBIRTH
- Acronym
- REBIRTH
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- REBIRTH / REBIRTH
- Conditions
- Patient Satisfaction, Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,266 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 19 Aug 2027 (estimated)
- Study completion
- 19 Aug 2028 (estimated)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial access | Active comparator | Procedure: Radial AccessRadial 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. |
| State-of-the-art femoral access | Active comparator | Procedure: State-of-the-art femoral access with 18 gauge needle, Procedure: State-of-the-art femoral access with 21 gauge needleFemoral 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial AccessRadial Access | Procedure or surgery | Radial access |
| State-of-the-art femoral access with 18 gauge needleState-of-the-art femoral access with 18 gauge needle | Procedure or surgery | State-of-the-art femoral access |
| State-of-the-art femoral access with 21 gauge needleState-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. | Procedure or surgery | State-of-the-art femoral access |
Primary outcome
Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
Time frame: Evaluations will occur up to 30 days
17 secondary outcomes
Total number of BARC type 2, 3, or 5 bleeding events
Time frame: Evaluations will occur up to 30 days
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
Number of participants with Radial artery occlusion
Time frame: Evaluations will occur up to 30 days
Number of participants with Access site crossover
Time frame: Measured during procedure
Number of other vascular access related complications
Time frame: Evaluations will occur up to 30 days
Total procedure time
Time frame: Measured during procedure
Time to ambulation
Time frame: Measured up to 24 hours after procedure completion
Number of all cause death and cardiac death
Time frame: Evaluations will occur up to 30 days
Number of participants with Myocardial Infarction
Time frame: Evaluations will occur up to 30 days
Number of participants with Stroke
Time frame: Evaluations will occur up to 30 days
Number of participants with unplanned coronary revascularization
Time frame: Evaluations will occur up to 30 days
Measure of Radiation Dose
Time frame: Measured during procedure
Fluoroscopy Time
Time frame: Measured during procedure
Contrast volume
Time frame: Measured during procedure
Number of participants with Procedural Success
Time frame: Evaluations will occur up to 30 days
Duration of hospital stay and frequency of same day discharge
Time frame: Evaluations will occur up to 30 days
Patient Preference Survey: Radial Vs Femoral Access
Time frame: Evaluations will occur up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga Mastrodemos contact
Emmanouil Brilakis, MD, PhD principal investigator
Minneapolis Heart Institute Foundation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Access, State-of-the-art femoral access with 18 gauge needle and State-of-the-art femoral access with 21 gauge needle in people with Patient Satisfaction and Vascular Access Complication, run by Minneapolis Heart Institute Foundation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bavana Rangan, BDS, MPH, CCRP (612-863-3852, bavana.rangan@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) (time frame: Evaluations will occur up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.