Angioplasty Clinical Trial
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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