Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients (RESERVE)

Southern University of Science and Technology

Status: Unknown

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

Treatments: Procedure: Arterial access

Study type: Interventional

Funder types: Other

Identifiers

NCT04861389

RESERVE.01

Details and patient eligibility

About

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.

Enrollment: 414 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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414 participants in 2 patient groups

Distal transradial access (dTRA)

Experimental group

Description:

Distal transradial access for primary percutaneous coronary intervention in STEMI patients

Treatment:

Procedure: Arterial access

Transradial access (TRA)

Active Comparator group

Description:

Transradial access for primary percutaneous coronary intervention in STEMI patients

Treatment:

Procedure: Arterial access