NCT05604976

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 9, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

October 9, 2022

Last Update Submit

November 8, 2023

Conditions

ST Elevation Myocardial Infarction

Keywords

Primary percutaneous coronary interventionDoor-to-balloon timeguiding catheter

Outcome Measures

Primary Outcomes (1)

  • Sheath-to-first device activation time

    Time from insertion of sheath to reperfusion treatment apparatus (First device activation)

    the end of PCI

Secondary Outcomes (10)

  • Door-to-balloon time

    the end of PCI

  • Total ischemia time

    the end of PCI

  • Fluoroscopy time and fluoroscopy dose

    the end of PCI

  • Amount of contrast medium

    the end of PCI

  • Number of catheters used

    the end of PCI

  • +5 more secondary outcomes

Study Arms (2)

SC-PCI

EXPERIMENTAL

Primary PCI is initiated with a universal guiding catheter (Ikari left). The guiding catheter is used to contrast the left and right coronary arteries and PCI is started directly. This method does not require a catheter exchange. It is Single Catheter PCI (SC-PCI) method.

Device: Percutaneous coronary intervention

Conventional

ACTIVE COMPARATOR

Primary PCI is initiated with a diagnostic catheter. The catheter is used to contrast one of the coronary arteries. Then, the catheter is replaced with a contralateral side diagnostic catheter. Then, the catheter is replaced with a guiding catheter and PCI is started.

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionDEVICE

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

ConventionalSC-PCI

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 21 years or older
  • Acute ST-segment elevation myocardial infarction
  • Patients indicated for Primary PCI within 12 hours after onset

You may not qualify if:

  • Patients with shock requiring insertion of Impella, ECMO or IABP before PCI
  • Patients requiring cardiopulmonary resuscitation due to cardiac arrest
  • Patients requiring temporary pacemaker due to bradycardia
  • Patients undergoing dialysis
  • Patients judged by the attending physician to be inappropriate for registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Related Publications (7)

  • Lee KH, Torii S, Oguri M, Miyaji T, Kiyooka T, Ono Y, Asada K, Adachi T, Takahashi A, Ikari Y. Reduction of door-to-balloon time in patients with ST-elevation myocardial infarction by single-catheter primary percutaneous coronary intervention method. Catheter Cardiovasc Interv. 2022 Feb;99(2):314-321. doi: 10.1002/ccd.29797. Epub 2021 May 31.

    PMID: 34057275RESULT

  • Torii S, Fujii T, Murakami T, Nakazawa G, Ijichi T, Nakano M, Ohno Y, Shinozaki N, Yoshimachi F, Ikari Y. Impact of a single universal guiding catheter on door-to-balloon time in primary transradial coronary intervention for ST segment elevation myocardial infarction. Cardiovasc Interv Ther. 2017 Apr;32(2):114-119. doi: 10.1007/s12928-016-0395-z. Epub 2016 Apr 28.

    PMID: 27125428RESULT

  • Youssef AA, Hsieh YK, Cheng CI, Wu CJ. A single transradial guiding catheter for right and left coronary angiography and intervention. EuroIntervention. 2008 Jan;3(4):475-81. doi: 10.4244/eijv3i4a85.

    PMID: 19736091RESULT

  • Ikari Y, Masuda N, Matsukage T, Ogata N, Nakazawa G, Tanabe T, Morino Y. Backup force of guiding catheters for the right coronary artery in transfemoral and transradial interventions. J Invasive Cardiol. 2009 Nov;21(11):570-4.

    PMID: 19901410RESULT

  • Ikari Y, Nagaoka M, Kim JY, Morino Y, Tanabe T. The physics of guiding catheters for the left coronary artery in transfemoral and transradial interventions. J Invasive Cardiol. 2005 Dec;17(12):636-41.

    PMID: 16327043RESULT

  • Ikari Y, Nakajima H, Iijima R, Aoki J, Tanabe K, Nakayama T, Miyazawa A, Hatori M, Kyouno H, Tanimoto S, Amiya E, Nakazawa G, Onuma Y, Hara K. Initial characterization of Ikari Guide catheter for transradial coronary intervention. J Invasive Cardiol. 2004 Feb;16(2):65-8.

    PMID: 14760193RESULT

  • Ikari Y, Ochiai M, Hangaishi M, Ohno M, Taguchi J, Hara K, Isshiki T, Tamura T, Yamaguchi T. Novel guide catheter for left coronary intervention via a right upper limb approach. Cathet Cardiovasc Diagn. 1998 Jun;44(2):244-7. doi: 10.1002/(sici)1097-0304(199806)44:23.0.co;2-l.

    PMID: 9637453RESULT

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Sho Torii, MD

    Tokai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study participants are randomly divided into two groups: one in which Primary PCI is initiated with a universal guiding catheter and the other with a diagnostic catheter. Compare time from sheath insertion to first device activation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Cardiology

Study Record Dates

First Submitted

October 9, 2022

First Posted

November 3, 2022

Study Start

November 1, 2022

Primary Completion

December 20, 2024

Study Completion

December 20, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

There are no plans to obtain IPD consent from patients.

Locations

JP(1)