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

Completed · Phase 2

Conditions studied: Angioplasty

In brief

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.

Key facts

Study ID

NCT00399646

Run by

Shockwave Medical, Inc.

People needed

145

Starts

2005-11-01

Expected to finish

2009-03-01

Last updated by the study team

2009-05-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients in whom coronary artery angiography is indicated and angioplasty and stenting is being considered.
• Single vessel disease of an artery with a lesion assessable to standard coronary guidewires and are scheduled or indicated for percutaneous coronary intervention.
• A maximum of one lesion requiring treatment (angioplasty +/- stenting) to an intended arterial diameter of 2.5 mm - 4.0 mm.
• Target stent length of 15 mm - 32 mm, where a single stent can adequately cover the lesion.
• Stenotic de novo lesions in native coronary arteries.

You may not qualify if…

• Women who are pregnant.
• Participation in a study involving investigational drugs or devices during the last six months.
• Patients with previous stenting in the target vessel area.
• Patients who experienced a myocardial infarction, Braunwald Class C, and very unstable Braunwald Class B3 within 6 weeks prior to the procedure or have unstable angina pectoris.
• Patients who are experiencing TIA's or minor or major strokes within six months prior to procedure.
• Contraindicated for antiplatelet and/or anticoagulation medications.
• Symptoms of cardiogenic shock.
• Patients who underwent a staged procedure 30 days prior to enrolment and/or were scheduled to have a staged procedure 14 days after treatment.
• Significant liver or kidney disease or malignancy.
• Patients scheduled for any other surgery or other procedure within 30 days.
• Severe peripheral vascular disease preventing femoral access.
• Left ventricle ejection fraction of < 35%.
• Total occlusion of target vessel.
• A blood pressure in excess of 180 mmHg at the time of the angiography.
• Visible thrombus, filling defect, or ulceration in the target artery.
• Severely calcified lesions which suggest that balloon pre-dilatation will not achieve adequate luminal diameter to allow successful stent delivery and deployment.
• The target lesion is beyond a left main artery stenosis > 50%.
• Contraindicated for CABG.
• Coronary spasm in the absence of a significant stenosis.
• Requiring treatment of more than two lesions.
• Requiring treatment with atherectomy.
• Lesions in surgical conduits - saphenous vein grafts, internal mammary arteries, or radial arteries.
• Unprotected left main coronary artery.
• Diffuse disease.
• Excessive tortuosity of proximal segment.

Where it is running

• UC Irvine Medical Center — Orange, California, United States
• Mercy Heart Institute — Sacramento, California, United States
• Pasco Cardiology Center — Hudson, Florida, United States
• Baptist Miami Hospital — Miami, Florida, United States
• Florida Cardiovascular Institute — Tampa, Florida, United States
• Sinai Hospital — Baltimore, Maryland, United States
• Columbia Presbyterian Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Tyler Cardiovascular Consultants — Tyler, Texas, United States
• Vancouver Hospital — Vancouver, British Columbia, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• Amphia Hospital — Breda, The Netherlands, Netherlands
• Leiden University Medical Center — Leiden, The Netherlands, Netherlands
• Medisch Centrum Rijmond Zuid — Rotterdam, The Netherlands, Netherlands
• University Medical Center Rotterdam — Rotterdam, The Netherlands, Netherlands

Full record on ClinicalTrials.gov

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