Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients

Radial Artery Occlusion Clinical Trial

— RESERVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861389
• Other study ID #: RESERVE.01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2021
• Source: Shenzhen People's Hospital
• Contact: Xin Sun, MD
• Phone: +86-755-22942705
• Email: sunxinflying[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Arterial access
Arterial access for primary percutaneous coronary intervention in STEMI patients

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The RAO incidence during hospitalization	The incidence of radial artery occlusion during hospitalization	7 days
Secondary	Puncture time	Puncture time	During the intervention
Secondary	Compression time	Compression time	4-24 hours
Secondary	Puncture success rate	Puncture success rate	During the intervention
Secondary	Incidence of hematoma, finger numbness or pain during hospitalization	Incidence of hematoma, finger numbness or pain during hospitalization	7days
Secondary	Incidence of RAO at 1 and 6 months after surgery	Incidence of RAO at 1 and 6 months after surgery	1 and 6 months