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NCT Number: NCT04941638

Comparison of Vascular Access in STEMI

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.

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

About this study

Recently, DRA has gained the interest of interventional cardiologists and previous studies have demonstrated several advantages including patient and operator comfort, shorter hemostasis duration, less bleeding, and access-site complications over PRA. More recently, randomized trial demonstrated that DRA prevents radial artery occlusion after the procedure compared with PRA. From this perspective, DRA could be considered an alternative access route for primary PCI in selected STEMI patients using potent P2Y12 inhibitors such as ticagrelor or prasugrel, or glycoprotein IIb/IIIa inhibitors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refractory cardiogenic shock requiring extracorporeal membrane oxygenation (ECMO)

Treatment and study plan

Distal radial access

Procedure

Vascular access for primary PCI in patients with STEMI

Other names: Proximal radial access, Femoral access

Primary outcomes

  1. access-site complication

    Time frame: 1 month

    puncture site related complication

Secondary outcomes

  1. The success rate of the puncture

    Time frame: Through procedure

    The success rate (%) of vascular puncture

  2. The success rate of the primary PCI

    Time frame: Through procedure

    Success rate (%) = Successful primary PCI / All PCI procedures

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

    Time frame: Through procedure

    Puncture time = time interval from local anesthesia induction to successful sheath cannulation.

    Door-to-wiring time = time elapsed from arrival of patient at the emergency department to guide wire passage through the lesion.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Comparison of Distal Radial, Proximal Radial and Femoral Access in ST-Segment Elevation Myocardial Infarction

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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