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Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations.

NCT00399646 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2009-05-13

No results posted yet for this study

Summary

The purpose of the Metricath Gemini System is to pre-dilate the target treatment area, take arterial lumen measurements in a native section of artery or within the deployed stent and perform further dilation of the deployed stent if required. In this manner, the Metricath Gemini System can assist the Interventionalist by providing arterial measurements prior to stenting, performing pre-stenting angioplasty, taking within stent measurements to help determine if the stent is fully deployed, and by performing post-stenting dilations to further dilate the stent if required.

Conditions

  • Angioplasty

Interventions

DEVICE

Metricath Gemini System

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Willem van der Giessen, MD · Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands

  • Evelyn Regar, MD · Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands

  • David Kandzari, MD · Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, USA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-11-30
Completion
2009-03-31

Countries

  • United States
  • Canada
  • Netherlands

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 NCT00399646 on ClinicalTrials.gov