CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 145 enrolled
Drug / intervention
Metricath Gemini Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00399646
NCT00399646Phase 2Completed

Gemini Angioplasty and Arterial Measurement Evaluation (GAAME) An Evaluation of the Metricath Gemini System, a Percutaneous Interventional Device Intended to Make Arterial Lumen Measurements and Perform Percutaneous Transluminal Angioplasty Dilations.

Shockwave Medical, Inc.·interventional·Posted Nov 15, 2006·Updated May 13, 2009

In Brief

A Phase 2 clinical trial evaluating Metricath Gemini System for Angioplasty. Completed, enrolled 145 participants across 16 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAngioplasty
CountriesCanada, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2006
Enrollment StartNov 1, 2005
Primary CompletionNov 1, 2007
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.6 years ago

Interventions

Metricath Gemini Systemdevice