NCT04941638

Brief Summary

Distal radial access (DRA) has recently introduced and previous studies have demonstrated that it is feasible option, showing several advantages including less bleeding and access-site complications over proximal radial access (PRA). Previous study reported the feasibility of DRA as an alternative option for primary percutaneous coronary intervention (PCI) in STEMI patients without major complication. However, comparison study of each vascular access for primary PCI have not been conducted until now. Here, The investigators aim to compare the DRA, PRA and femoral access (FA), in terms of feasibility and safety, in patients with STEMI. This is a retrospective study with patients who underwent primary PCI for STEMI between March 2020 to May 2021. The primary outcome of this study is the access-site complication including major bleeding requiring transfusion or surgery, hematoma and arterial occlusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

April 22, 2022

Status Verified

June 1, 2021

Enrollment Period

5 days

First QC Date

June 18, 2021

Last Update Submit

April 20, 2022

Conditions

Keywords

Distal radial accessSnuffbox approachST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • access-site complication

    puncture site related complication

    1 month

Secondary Outcomes (3)

  • The success rate of the puncture

    Through procedure

  • The success rate of the primary PCI

    Through procedure

  • The percentage of puncture time in Door-to-wiring time (%)

    Through procedure

Interventions

Vascular access for primary PCI in patients with STEMI

Also known as: Proximal radial access, Femoral access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent primary PCI for STEMI without ECMO

You may qualify if:

  • Between March 2020 to May 2021, patients who underwent primary PCI for STEMI at the Yongin Severance Hospital

You may not qualify if:

  • Refractory cardiogenic shock requiring extracorporeal membrane oxygenation (ECMO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yongcheol Kim

    Yongin Severance Hopistal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 28, 2021

Study Start

June 17, 2021

Primary Completion

June 22, 2021

Study Completion

June 29, 2021

Last Updated

April 22, 2022

Record last verified: 2021-06

Locations