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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Occlusion; Acute ST-segment Elevation Myocardial Infarction; Distal Radial Artery Approach
• Intervention / Treatment: Procedure: Arterial access

• Study Type: Interventional
• Enrollment (Anticipated): 414
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Sun, MD; Phone Number: +86-755-22942705; Email: sunxinflying@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • Recruiting
      • Shenzhen People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: RESERVE.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No