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NCT07888738
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
Conditions: Hemostasis, Distal Radial Artery Access (dTRA)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 320
Sponsor: Terumo Europe N.V.
Location: Krankenhaus Eisenstadt Eisenstadt
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.
Eligibility Criteria
Inclusion Criteria:
* 18 years of age or older
* Successful insertion of Distal Radial Sheath
* Scheduled to undergo a heart procedure through a blood vessel in the wrist near the base of the thumb (called distal radial access)
* Suitable blood vessel in the wrist for the procedure;
* Successful placement of the required equipment.
* Willingness to participate by signing this informed consent form.
Exclusion Criteria:
* Having a certain type of heart attack requiring emergency treatment
* Dialysis
* Doctor is unable to perform the procedure through the planned blood vessel in the wrist near the base of your thumb
* Procedure is started through a different blood vessel and then switched to the blood vessel in the wrist near the base of the thumb.
* A previous distal radial access procedure has been performed in the same arm, or
* The participant is in a life-threatening condition in which the heart cannot pump sufficient blood to the body (known as cardiogenic shock)
Source: ClinicalTrials.gov (NCT07888738). StuddyBuddy aggregates publicly available trial information.