Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients

Not Applicable

• Conditions: Radial Artery Occlusion; Distal Radial Artery Approach; Acute ST-segment Elevation Myocardial Infarction
• Interventions: Procedure: Arterial access

• Registration Number: NCT04861389
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-29
• Study Start: 2021-01-01
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-26
• Study First Posted: 2021-04-27
• Last Update Posted: 2021-04-27
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal transradial access (dTRA)	Arterial access	Distal transradial access for primary percutaneous coronary intervention in STEMI patients
Transradial access (TRA)	Arterial access	Transradial access for primary percutaneous coronary intervention in STEMI patients

Primary Outcome Measures

Name	Time	Method
The RAO incidence during hospitalization	7 days	The incidence of radial artery occlusion during hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China