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Single Catheter Primary Percutaneous Coronary Intervention Method in Patients With ST Elevation Myocardial Infarction

NCT05604976 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2023-11-13

No results posted yet for this study

Summary

The goal of this clinical trial is to test reducing procedure time of percutaneous coronary intervention (PCI) in ST elevation myocardial infarction by single catheter PCI (SC-PCI) method. The main question it aims to answer is:

• \[question 1\] SC-PCI method is skipping catheter exchange with use of a right and left dual purpose universal guiding catheter Ikari Left curve. Does SC-PCI method reduce PCI procedure time? Participants will be randomly assigned to SC-PCI method or conventional method and emergency PCI is performed.

Researchers will compare time from sheath insertion to first device activation between the SC-PCI method and the conventional method.

Conditions

  • ST Elevation Myocardial Infarction

Interventions

DEVICE

Percutaneous coronary intervention

Primary PCI for ST elevation myocardial infarction initiating with a universal guiding catheter or an angiographic catheter

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Tokai University

    lead OTHER

Principal Investigators

  • Sho Torii, MD · Tokai University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-12-20
Completion
2025-12-20
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604976 on ClinicalTrials.gov