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Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04861389
Acronym
RESERVE
Enrollment
414
Registered
2021-04-27
Start date
2021-01-01
Completion date
2022-01-31
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

Arterial access for primary percutaneous coronary intervention in STEMI patients

Sponsors

Shenzhen People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The RAO incidence during hospitalization7 daysThe incidence of radial artery occlusion during hospitalization

Secondary

MeasureTime frameDescription
Puncture timeDuring the interventionPuncture time
Compression time4-24 hoursCompression time
Puncture success rateDuring the interventionPuncture success rate
Incidence of hematoma, finger numbness or pain during hospitalization7daysIncidence of hematoma, finger numbness or pain during hospitalization
Incidence of RAO at 1 and 6 months after surgery1 and 6 monthsIncidence of RAO at 1 and 6 months after surgery

Countries

China

Contacts

Primary ContactXin Sun, MD
sunxinflying@163.com+86-755-22942705

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026