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Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
Sponsor: Terumo Europe N.V.
Summary
This clinical study has been organised to learn more about the safety and use of the TR Band Distal device in patients who have had a heart procedure through a blood vessel in the wrist near the base of the thumb (called distal radial access). The study will look at how well the device helps stop bleeding after the procedure, while still allowing blood to flow normally through the blood vessel in the wrist.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
320
Start Date
2026-12-01
Completion Date
2027-11
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
TR Band Distal
Coronary procedure via distal radial access using the TR Band Distal
Locations (7)
Krankenhaus Eisenstadt
Eisenstadt, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium
CHU Charleroi
Charleroi, Belgium
Agaplesion Bethesda Hospital
Hamburg, Germany
Hospital of the Holy Spirit
Kempen, Germany
Ospedale S. Eugenio
Rome, Italy
Humanitas Research Hospital
Rozzano, Italy