Comparison of Vascular Access in STEMI

ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941638
• Other study ID #: DRA-STEMI
• Status: Completed
• Start date: June 17, 2021
• Est. completion date: June 29, 2021

Study information

• Verified date: June 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 29, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Distal radial access
Vascular access for primary PCI in patients with STEMI

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	access-site complication	puncture site related complication	1 month
Secondary	The success rate of the puncture	The success rate (%) of vascular puncture	Through procedure
Secondary	The success rate of the primary PCI	Success rate (%) = Successful primary PCI / All PCI procedures	Through procedure
Secondary	The percentage of puncture time in Door-to-wiring time (%)	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.	Through procedure