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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00399646

Public ClinicalTrials.gov record NCT00399646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 12:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Study identification

NCT ID
NCT00399646
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Shockwave Medical, Inc.
Industry
Enrollment
145 participants

Conditions and interventions

Conditions

Interventions

  • Metricath Gemini System Device

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2005
Primary completion
Oct 31, 2007
Completion
Feb 28, 2009
Last update posted
May 12, 2009

2005 – 2009

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
UC Irvine Medical Center Orange California 92868-4080
Mercy Heart Institute Sacramento California 95819-3633
Pasco Cardiology Center Hudson Florida 34667
Baptist Miami Hospital Miami Florida 33176
Florida Cardiovascular Institute Tampa Florida 33609
Sinai Hospital Baltimore Maryland 21215
Columbia Presbyterian Hospital New York New York 10032
Duke University Medical Center Durham North Carolina 27710
University of Oklahoma Oklahoma City Oklahoma 73104
Tyler Cardiovascular Consultants Tyler Texas 75701

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00399646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 12, 2009 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00399646 live on ClinicalTrials.gov.

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