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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Angioplasty

Intervention / Treatment
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* Device: Metricath Gemini System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Extremely angulated segments > 90°.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Metricath Gemini System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe the safety of the device, as determined by freedom from MACE (major adverse cardiac events) within 30 days post-procedure. |  | 30 days | 
| To observe the success of the device as determined by residual diameter stenosis |  | 30 days | 
| To evaluate the inflation of dilation balloon to desired pressure |  | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the successful delivery of catheter to target area |  | immediate | 
| To evaluate the performance of the device to measure arterial size |  | immediate |