Trial · NCT07888738
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
NCT07888738, Not yet recruiting, Terumo Europe N.V.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures. Trials, record NCT07888738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888738
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
- NCT number
- NCT07888738
- Status
- Not yet recruiting
- Enrollment
- 320 participants, estimated
- Lead sponsor
- Terumo Europe N.V.
- Conditions
- Hemostasis, Distal Radial Artery Access (dTRA)
- Interventions
- TR Band Distal
- First posted
- 2026-10-22
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Achieving Successful Hemostasis Within 24 Hours | 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). |
| Secondary | Time to hemostasis | From sheath removal until removal of the TR Band Distal device, up to 24 hours post-procedure | 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. |
| Secondary | Proportion of Subjects With Proximal Radial Artery Occlusion | Within 24 hours after the procedure | 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. |
| Secondary | Proportion of subjects achieving clinically relevant access-site hematoma | Within 24 hours after the procedure | 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. |
| Secondary | Proportion of subjects achieving freedom from other access-site and vascular complications within 24 hours post-procedure, including bleeding (BARC score) | Up to 24 hours after the procedure | 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. |
| Secondary | Proportion of subjects achieving freedom from other access-site and vascular complications within 24 hours post-procedure, including hematoma (EASY score 1 or higher) | Up to 24 hours after the procedure | 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. |
| Secondary | Patient-reported outcomes following distal radial access and hemostasis using the TR Band Distal device, assessed by Numeric Pain Rating Scale (NPRS) | (i) Periprocedural (during device wear), and (ii) Periprocedural (after removal of the TR Band Distal device but before hospital discharge) | 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. |
| Secondary | Patient-reported outcomes following distal radial access and hemostasis using the patient satisfaction questionnaire | Periprocedural (during device wear) | 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. |
| Secondary | Usability of the TR Band Distal device from the operator perspective, evaluated through a questionnaire completed | Periprocedural (after removal of the TR Band Distal device but before hospital discharge) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07888738
GET https://conductscience.org/api/trials/v1/NCT07888738/registered