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Guidewire for Chronic Total Occlusion

NCT00987610 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2015-05-04

No results posted yet for this study

Summary

Under the circumstances that appropriate first-choice guidewires for percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) have yet to be established, the objective of this study is to determine appropriate first-choice guidewires. G-FORCE study is a prospective multicenter randomized study between normal (distal tip size 0.014 inch) and slender (distal tip size 0.010 inch or less) guidewires. Primary end point is lesion penetration rate of the first choice guidewire.

Conditions

  • Coronary Occlusion

Interventions

DEVICE

Percutaneous coronary intervention (PCI)

PCI for chronic total occlusion is performed using either arm of guidewire

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Kaneka Medical America LLC

    collaborator INDUSTRY

  • Asahi Intech

    collaborator UNKNOWN

  • Terumo Medical Corporation

    collaborator INDUSTRY

  • Japan Lifeline

    collaborator UNKNOWN

  • Tokai University

    lead OTHER

Principal Investigators

  • Yuji Ikari, MD, PhD · Tokai University

  • Kazuaki Mitsudo, MD · Kurashiki Central Hospital

  • Osamu Kato, MD · Toyohashi Heart Center

  • Shigeru Saito, MD · Shonan Kamakura General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT00987610 on ClinicalTrials.gov