Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients

Study Overview
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Brief Summary
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The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for percutaneous intervention. The literature reported that distal transradial access (dTRA) significantly reduced RAO after elective PCI, but the application of dTRA in emergency PCI in STEMI has not been reported. We have completed 126 cases of dTRA undergoing emergency PCI after STEMI, which has been preliminarily confirmed to be safe and effective. A single-center, open, prospective, randomized controlled study is planned to compare the use of dTRA and TRA in emergency PCI in STEMI patients. The primary endpoint was the INCIDENCE of RAO within 24 hours after surgery. This clinical study verified that dTRA compared with TRA could reduce the RAO incidence of STEMI patients after emergency PCI. The project will explore a new artery approach to reduce RAO, and provide a basis for the selection of artery approach in STEMI emergency PCI patients.

Official Title
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The Comparison of Distal Transradial Access and Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients（RESERVE Trial） A Single-center, Open, Prospective, Randomized Controlled Trial

Conditions
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Acute ST-segment Elevation Myocardial Infarction, Radial Artery Occlusion, Distal Radial Artery Approach

Intervention / Treatment
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* Procedure: Arterial access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of STEMI To undergo emergency PCI treatment Palpable pulsation of the radial artery and distal radial artery Exclusion Criteria: Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis Suspicious left main block of electrocardiogram Had used the radial artery percutaneous interventional treatment before Cardiogenic shock

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal transradial access (dTRA)<br>Distal transradial access for primary percutaneous coronary intervention in STEMI patients | Procedure: Arterial access<br>* Arterial access for primary percutaneous coronary intervention in STEMI patients<br>|
| Active Comparator: Transradial access (TRA)<br>Transradial access for primary percutaneous coronary intervention in STEMI patients | Procedure: Arterial access<br>* Arterial access for primary percutaneous coronary intervention in STEMI patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The RAO incidence during hospitalization | The incidence of radial artery occlusion during hospitalization | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture time | Puncture time | During the intervention | 
| Compression time | Compression time | 4-24 hours | 
| Puncture success rate | Puncture success rate | During the intervention | 
| Incidence of hematoma, finger numbness or pain during hospitalization | Incidence of hematoma, finger numbness or pain during hospitalization | 7days | 
| Incidence of RAO at 1 and 6 months after surgery | Incidence of RAO at 1 and 6 months after surgery | 1 and 6 months |