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.
Several recent clinical studies have suggested that proper vascular stent deployment directly affects clinical outcome, and the rate of re-stenosis. These studies suggest that angiography alone is not sufficient to ensure proper vascular stent deployment, and that re-stenosis rates will decline if proper stent apposition has occurred. The importance of proper stent sizing and apposition is further emphasised with the increasing use of drug eluting stents, the drug effects of which are only realized upon contact with the arterial wall. Angiometrx Inc. developed the Metricath Arterial Measurement System in response to the need for increased stent sizing and deployment. The Metricath System measures the diameter and cross sectional area of arteries using an intravascular balloon catheter attached to a computerized console. Considering the ease and rapidity of obtaining Metricath results, this technique may form an alternative to evaluate vessel area and stent expansion. The Metricath System was 510(k) cleared in the U.S. in June, 2003, and received European and Canadian market approvals in 2004. Angiometrx Inc. has now developed the next generation of Metricath System, which incorporates a second balloon on the catheter, intended for angioplasty purposes. The Metricath Gemini System is comprised of a dual balloon catheter which is attached to the same Metricath computerized console as the Metricath System. As with the Metricath System, the Metricath Console operates the inflation and deflation of the Gemini measurement balloon and provides arterial cross-sectional area and diameter. The Metricath Gemini angioplasty balloon is controlled separately in the traditional manner using a hand-held inflation device, attached to a port in the hub of the catheter.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
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
...and 6 more locations
To observe the safety of the device, as determined by freedom from MACE (major adverse cardiac events) within 30 days post-procedure.
Time frame: 30 days
To observe the success of the device as determined by residual diameter stenosis
Time frame: 30 days
To evaluate the inflation of dilation balloon to desired pressure
Time frame: immediate
To evaluate the successful delivery of catheter to target area
Time frame: immediate
To evaluate the performance of the device to measure arterial size
Time frame: immediate
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