Clinical trial NCT05461781: Distal Radial Access for Primary PCI in STEMI Patients to Prevent RAO
Official title: Distal Radial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST Segment Elevation Myocardial Infarction
Keywords: radial artery occlusion
primary percutaneous coronary intervention
distal radial access
conventional transradial access
Lead sponsor: Beijing Luhe Hospital
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, open-label, parallel randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* ST-segment elevation myocardial infarction for primary percuteous coronary intervention
* Palpable pulses on both access sites of the radial artery
* Informed consent

Exclusion Criteria:

* Thrombolysis before primary percutaneous coronary intervention
* Previous CABG or radio-cephalic fistula using radial artery
* Cardiogenic shock
* Severe arrhythmias
* Severe liver and kidney dysfunction
* Pregnancy
* Enrolment in another study within 1 month
* Inability to obtain written informed consent

Primary outcomes:
measure: radial artery occlusion
timeFrame: at 24 hours after procedure
Secondary outcomes:
measure: the rate of successful puncture
timeFrame: Immediately post-procedurally
measure: puncture time
timeFrame: Immediately post-procedurally
measure: first medical contact to device (FMC2D) time
timeFrame: Immediately post-procedurally
measure: procedural time
timeFrame: Immediately post-procedurally
measure: hemostasis time
timeFrame: at 24 hours after procedure
measure: access-related complications
timeFrame: at 24 hours after procedure
measure: hand function
timeFrame: 1 week after procedure
measure: radial artery occlusion
timeFrame: 30days after procedure
measure: radial aretry injury
timeFrame: Immediately post-procedurally
measure: major adverse cardiovascular events(MACE)
timeFrame: 30 days after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe hospital
state: Beijing
Study officials:
affiliation: Beijing Luhe Hospital
name: Jincheng Guo
role: STUDY_CHAIR
References: