An observational study in Hemostasis and Distal Radial Artery Access (dTRA), sponsored by Terumo Europe N.V.. Not yet recruiting at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Terumo Europe N.V. (part of Terumo Corporation) · Observational
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.
Individuals may be invited to participate in this clinical study if they have been offered a procedure to examine the blood vessels of the heart, treat any narrowing or blockage, or both. The procedure involves inserting a thin flexible tube (catheter) through a blood vessel in the wrist near the base of the thumb, which allows the doctor to reach the heart. The procedure will be carried out as part of the individual's planned medical treatment.
The TR Band Distal is a band placed around the hand after the procedure. It contains a small clear cushion that gently presses on the area where the artery was accessed to help stop bleeding. The band is temporary and is removed once bleeding has stopped.
Terumo Europe N.V. is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients receiving a diagnostic or interventional procedure via the distal radial artery. Up to 10 clinical investigation sites located in Europe will participate. Up to 10 clinical investigation sites located in Europe will participate.
The maximum number of subjects per site is 80.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Coronary procedure via distal radial access using the TR Band Distal
Proportion of Subjects Achieving Successful Hemostasis Within 24 Hours
Proportion of subjects achieving successful hemostasis within 24 hours following a coronary procedure performed via distal radial access. Successful hemostasis is defined as the absence of proximal radial artery occlusion (blockage of the artery), confirmed by Doppler ultrasound, and the absence of clinically relevant access-site hematoma (modified EASY grade II or higher).
Time frame: Within 24 hours following the index procedure
Time to hemostasis
Time to hemostasis, measured in minutes, between the removal of the procedural sheath up to the removal of the TR Band Distal device without the re occurrence of bleeding.
Time frame: From sheath removal until removal of the TR Band Distal device, up to 24 hours post-procedure
Proportion of Subjects With Proximal Radial Artery Occlusion
Proportion of subjects with proximal radial artery occlusion (blocked artery) within 24 hours after the procedure. Doppler ultrasound will be used to assess whether blood continues to flow normally through the artery.
Time frame: Within 24 hours after the procedure
Proportion of subjects achieving clinically relevant access-site hematoma
Proportion of subjects with clinically relevant access-site hematoma within 24 hours after the procedure, defined as a modified EASY grade II, III, IV, or V hematoma. The wrist access site will be examined before hospital discharge to assess for bruising or swelling around the puncture site.
Time frame: Within 24 hours after the procedure
Proportion of subjects achieving freedom from other access-site and vascular complications within 24 hours post-procedure, including bleeding (BARC score)
Bleeding events will be classified according to the Bleeding Academic Research Consortium (BARC) criteria,a standardized bleeding classification system ranging from Type 0 to Type 5, where: Type 0 = no bleeding, Type 5 = fatal bleeding. Higher BARC scores indicate more severe bleeding and therefore a worse clinical outcome.
Time frame: Up to 24 hours after the procedure
Proportion of subjects achieving freedom from other access-site and vascular complications within 24 hours post-procedure, including hematoma (EASY score 1 or higher)
Hematomas (bruising around the wrist access site) will be classified using the modified EASY (Early Discharge After Transradial Stenting of Coronary Arteries Study) hematoma scale, which categorizes bruising according to its size and severity, from Type Ia (a small bruise around the wrist puncture site that remains below the wrist bone) to Type V (a hematoma associated with an ischemic threat to the hand). Higher grades indicate a worse clinical outcome.
Time frame: Up to 24 hours after the procedure
Patient-reported outcomes following distal radial access and hemostasis using the TR Band Distal device, assessed by Numeric Pain Rating Scale (NPRS)
Patient-reported pain intensity will be evaluated using a standardized Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 to 10, where 0 indicates "No pain" and 10 indicates "Worst pain imaginable." Higher score indicate worse outcome.
Time frame: (i) Periprocedural (during device wear), and (ii) Periprocedural (after removal of the TR Band Distal device but before hospital discharge)
Patient-reported outcomes following distal radial access and hemostasis using the patient satisfaction questionnaire
Patient satisfaction will be assessed using a study-specific questionnaire that evaluates comfort while wearing the device and the ability to move the hand and fingers, and the overall satisfaction. Each item is assessed using four ordered response categories ranging from the least favorable to the most favorable response (e.g., poor to excellent, very uncomfortable to very comfortable, or very dissatisfied to very satisfied).. Patient should only select one response for each question. Responses in more favorable categories indicate better outcome.
Time frame: Periprocedural (during device wear)
Usability of the TR Band Distal device from the operator perspective, evaluated through a questionnaire completed
Data on device usability and operator satisfaction will be collected using an operator questionnaire completed by the operator who deployed the TR Band Distal device. The questionnaire will capture the operator's assessment of device handling, ease of application, inflation/deflation process, stability during use, and overall satisfaction. The questionnaire consists of 11 multiple-choice questions, each with four response options, and only one response may be selected for each question.
Time frame: Periprocedural (after removal of the TR Band Distal device but before hospital discharge)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.