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Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.
Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| distal radial access | Experimental | Distal radial access for primary percutaneous coronary intervention in STEMI patients |
|
| conventional transradial access | Active Comparator | conventional transradial access for primary percutaneous coronary intervention in STEMI patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| distal radial access | Procedure | primary percutaneous coronary intervention via distal radial access |
|
| Measure | Description | Time Frame |
|---|---|---|
| radial artery occlusion | The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound. | at 24 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of successful puncture | Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery. | Immediately post-procedurally |
| puncture time | The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jincheng Guo | Beijing Luhe Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Luhe hospital | Beijing | Beijing Municipality | 101149 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40128873 | Derived | Li Z, Wang Y, Song J, Wang S, Wang Y, Wu Y, Wang H, Liu Z, Yan R, Zhai G, Guo J. Distal radial access to prevent radial artery occlusion for STEMI patients (RAPID III): a randomized controlled trial. BMC Med. 2025 Mar 24;23(1):173. doi: 10.1186/s12916-025-04005-1. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single-center, open-label, parallel randomized controlled trial
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| conventional transradial access | Procedure | primary percutaneous coronary intervention via conventional transradial access |
|
| Immediately post-procedurally |
| first medical contact to device (FMC2D) time | FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation. | Immediately post-procedurally |
| procedural time | Procedural time defined as the time interval between local anesthesia to sheath removal. | Immediately post-procedurally |
| hemostasis time | Hemostasis time was defined as the time between sheath removal to complete hemostasis. | at 24 hours after procedure |
| access-related complications | Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma. | at 24 hours after procedure |
| hand function | Hand function was evaluated by QuickDASH questionnaire. | 1 week after procedure |
| radial artery occlusion | The radial artery occlusion will be evaluated 1 month after procedure by ultrasound. | 30days after procedure |
| radial aretry injury | Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography. | Immediately post-procedurally |
| major adverse cardiovascular events(MACE) | MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding. | 30 days after procedure |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |