HemostasisEASY DISTALNCT07888738
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
An observational study of Hemostasis and Distal Radial Artery Access (dTRA), run by Terumo Europe N.V. at 7 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis, Distal Radial Artery Access (dTRA)
- What is being tested?
- TR Band Distal
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Dec 2026to Nov 2027
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
Belgium2 sites
Cliniques universitaires Saint-Luc
Brussels, 1200
Joelle Kefer, +32 27642888, Joelle.kefer@uclouvain.be
CHU Charleroi
Charleroi, 6042
Adel Aminian, +32 478938648, adaminian@hotmail.com
Germany2 sites
Agaplesion Bethesda Hospital
Hamburg, 21029
Karsten Schenke, +4940725542330, Karsten.schenke@agaplesion.de
Hospital of the Holy Spirit
Kempen, 47906
Rostislav Prog, +4921521421218, rostislav.prog@artemed.de
Italy2 sites
Ospedale S. Eugenio
Rome, 00144
Gregory Sgueglia, +39 347 1718 642, g.a.sgueglia@gmail.com
Humanitas Research Hospital
Rozzano, 20089
Gabriele Luigi Gasparini, +39 28224675, gabriele.gasparini@humanitas.it
Austria1 site
Krankenhaus Eisenstadt
Eisenstadt, 7000
Mathias Stöckl, +4326826012070, Mathias.stoeckl@bbeisen.at
About this study
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.
Read the detailed description
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.
- Conditions
- Hemostasis, Distal Radial Artery Access (dTRA)
- Being tested
- TR Band Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR Band DistalDevice
Coronary procedure via distal radial access using the TR Band Distal
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours following the index procedure
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: (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.
Measured: 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.
Measured: Periprocedural (after removal of the TR Band Distal device but before hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888738
- Sponsor's protocol ID
- T145E4
- Acronym
- EASY DISTAL
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
- ClinicalTrials.gov ID
- NCT07888738
- Acronym / sponsor ID
- EASY DISTAL / T145E4
- Conditions
- Hemostasis, Distal Radial Artery Access (dTRA)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Oct 2026 (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 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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| TR Band DistalCoronary procedure via distal radial access using the TR Band Distal | Device | – |
Primary outcome
Proportion of Subjects Achieving Successful Hemostasis Within 24 Hours
Time frame: Within 24 hours following the index procedure
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).
8 secondary outcomes
Time to hemostasis
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
Time frame: Within 24 hours after the procedure
Proportion of subjects achieving clinically relevant access-site hematoma
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)
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)
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)
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
Time frame: Periprocedural (during device wear)
Usability of the TR Band Distal device from the operator perspective, evaluated through a questionnaire completed
Time frame: Periprocedural (after removal of the TR Band Distal device but before hospital discharge)
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostasis and Distal Radial Artery Access (dTRA), run by Terumo Europe N.V. at 7 sites in 4 countries.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Germany, Italy, Austria. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Achieving Successful Hemostasis Within 24 Hours (time frame: Within 24 hours following the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.