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NCT04077762 · ClinicalTrials.gov registry record · NA
Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
A NA study of Patient Satisfaction and Vascular Access Complication, sponsored by Minneapolis Heart Institute Foundation.
- Recruiting
- Registry status
- NA
- Development phase
- 3,266
- Enrollment target
- 6
- Study locations
NCT04077762 is a NA study of Patient Satisfaction and Vascular Access Complication that is actively recruiting participants, run by Minneapolis Heart Institute Foundation. The registered enrollment target is 3,266 participants, above the 304-participant average among 20 other Patient Satisfaction trials with a reported enrollment target (974% higher). The trial reports 6 study locations across 6 states.
The verdict
NCT04077762, a NA study of Patient Satisfaction and Vascular Access Complication, is actively recruiting participants, sponsored by Minneapolis Heart Institute Foundation.
- RECRUITING
- Registry status
- NA
- Development phase
- 3,266 participants
- Enrollment target
- 6
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Radial Access
- PROCEDURE State-of-the-art femoral access with 18 gauge needle
- PROCEDURE State-of-the-art femoral access with 21 gauge needle
Study Locations (6)
California
- San Francisco VA Medical Center - San Francisco
Florida
- Mayo Clinic Florida - Jacksonville
Georgia
- Joseph Maxwell Cleland Atlanta VA Medical Center - Decatur
Michigan
- Henry Ford Hospital - Detroit
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
Oklahoma
- Oklahoma Heart Hospital - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,266 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2028-08-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04077762
The ClinicalTrials.gov registry entry for NCT04077762 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 3,266 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 304-participant average among 20 other Patient Satisfaction trials with a reported enrollment target (974% higher). The listed sponsor is Minneapolis Heart Institute Foundation, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Patient Satisfaction appearing as the primary indexed condition, and to 3 interventions - of which Radial Access is the first listed.
NCT04077762 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04077762 about?
NCT04077762 is a clinical study titled "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 grou...
What is the current status of trial NCT04077762?
This trial is currently recruiting. It is a NA study. The enrollment target is 3,266 participants. The study started on 2019-11-15. Estimated completion is 2028-08-19.
What conditions does trial NCT04077762 study?
This clinical trial studies the following conditions: Patient Satisfaction, Vascular Access Complication.
What interventions are being tested in trial NCT04077762?
The interventions under investigation include: Radial Access (PROCEDURE), State-of-the-art femoral access with 18 gauge needle (PROCEDURE), State-of-the-art femoral access with 21 gauge needle (PROCEDURE).
Who is sponsoring clinical trial NCT04077762?
This trial is sponsored by Minneapolis Heart Institute Foundation, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04077762 being conducted?
This trial has 6 study locations across California, Florida, Georgia, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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