Beijing Luhe hospital
Beijing, Beijing Municipality, 101149, China
NCT Number: NCT05461781
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 101149, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
primary percutaneous coronary intervention via distal radial access
primary percutaneous coronary intervention via conventional transradial access
Time frame: at 24 hours after procedure
The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.
Time frame: Immediately post-procedurally
Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery.
Time frame: Immediately post-procedurally
The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion.
Time frame: Immediately post-procedurally
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.
Time frame: Immediately post-procedurally
Procedural time defined as the time interval between local anesthesia to sheath removal.
Time frame: at 24 hours after procedure
Hemostasis time was defined as the time between sheath removal to complete hemostasis.
Time frame: at 24 hours after procedure
Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma.
Time frame: 1 week after procedure
Hand function was evaluated by QuickDASH questionnaire.
Time frame: 30days after procedure
The radial artery occlusion will be evaluated 1 month after procedure by ultrasound.
Time frame: Immediately post-procedurally
Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography.
Time frame: 30 days after procedure
MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding.
Beijing Luhe Hospital
Other
Distal Radial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion
Acronym: RAPIDIII
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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