NCT05461781

Brief Summary

Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

July 14, 2022

Last Update Submit

March 7, 2025

Conditions

Keywords

radial artery occlusionprimary percutaneous coronary interventiondistal radial accessconventional transradial access

Outcome Measures

Primary Outcomes (1)

  • radial artery occlusion

    The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.

    at 24 hours after procedure

Secondary Outcomes (10)

  • the rate of successful puncture

    Immediately post-procedurally

  • puncture time

    Immediately post-procedurally

  • first medical contact to device (FMC2D) time

    Immediately post-procedurally

  • procedural time

    Immediately post-procedurally

  • hemostasis time

    at 24 hours after procedure

  • +5 more secondary outcomes

Study Arms (2)

distal radial access

EXPERIMENTAL

Distal radial access for primary percutaneous coronary intervention in STEMI patients

Procedure: distal radial access

conventional transradial access

ACTIVE COMPARATOR

conventional transradial access for primary percutaneous coronary intervention in STEMI patients

Procedure: conventional transradial access

Interventions

primary percutaneous coronary intervention via distal radial access

distal radial access

primary percutaneous coronary intervention via conventional transradial access

conventional transradial access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • ST-segment elevation myocardial infarction for primary percuteous coronary intervention
  • Palpable pulses on both access sites of the radial artery
  • Informed consent

You may not qualify if:

  • Thrombolysis before primary percutaneous coronary intervention
  • Previous CABG or radio-cephalic fistula using radial artery
  • Cardiogenic shock
  • Severe arrhythmias
  • Severe liver and kidney dysfunction
  • Pregnancy
  • Enrolment in another study within 1 month
  • Inability to obtain written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Luhe hospital

Beijing, Beijing Municipality, 101149, China

Location

Related Publications (1)

  • Li Z, Wang Y, Song J, Wang S, Wang Y, Wu Y, Wang H, Liu Z, Yan R, Zhai G, Guo J. Distal radial access to prevent radial artery occlusion for STEMI patients (RAPID III): a randomized controlled trial. BMC Med. 2025 Mar 24;23(1):173. doi: 10.1186/s12916-025-04005-1.

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionArterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jincheng Guo

    Beijing Luhe Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single-center, open-label, parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 18, 2022

Study Start

January 5, 2022

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations