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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04861389
Other study ID # RESERVE.01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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