Status:
COMPLETED
Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations.
Lead Sponsor:
Shockwave Medical, Inc.
Conditions:
Angioplasty
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 d...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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°.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00399646
Start Date
November 1 2005
End Date
March 1 2009
Last Update
May 13 2009
Active Locations (16)
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1
UC Irvine Medical Center
Orange, California, United States, 92868-4080
2
Mercy Heart Institute
Sacramento, California, United States, 95819-3633
3
Pasco Cardiology Center
Hudson, Florida, United States, 34667
4
Baptist Miami Hospital
Miami, Florida, United States, 33176