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A single center Pilot Clinical Registry Study of the" Acute Procedural" Safety and Efficacy of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the Treatment of Refractory Coronary Total Occlusions
Determine the safety and efficacy of the Stereotaxis PowerAssert™ 18 RF Wire System:
Primary - of recanalizing (crossing) coronary total occlusions within a stent.
Secondary - facilitated angioplasty at hospital discharge represented by
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RF Guidewire | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PowerAssert RF wire in crossing coronary in-stent chronic total occlusions | Device | Radio frequency ablation of chronic total occlusions within a stent of a coronary artery using Niobe Magnetic Navigation System (MNS) and the PowerAssert Radiofrequency Guidewire |
| Measure | Description | Time Frame |
|---|---|---|
| Primary RF wire success | Defined as reaching the true lumen of any branch distal to the total occlusion with the sole use of the RF wire with absence of major complications (Myocardial Infarction (MI), tamponade, emergency Cornary Artery Bypass graft (CABG) or death) | Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Facilitated RF wire Success: Procedure Success: Clinical Success | Facilitated RF wire success is defined as reaching the true lumen of any branch distal to the total occlusion with combined use of the RF wire and any approved mechanical guidewire with absence of major complications Procedure success defined as in-hospital device success and final residual stenosis < 30% on visual assessment, following adjunctive angioplasty, with absence of major complications Clinical success defined as device and procedure success during the concurrent hospital stay with absence of major complication |
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Inclusion Criteria:
Exclusion Criteria:
Under 18 years of age
Current participation in another study with any investigational drug or device
->TIMI 0 flow at target lesion site
Lesion >40mm. in length
Factors making follow-up or repeat angiography difficult or unlikely
Acute myocardial infarction less than 1 month before angioplasty
Contra-indication to emergency coronary artery bypass surgery
No access to cardiac surgery
Contra-indication to treatment with aspirin, ticlopidine, clopidogrel or heparin
Angiographic evidence of thrombus (filling defect proximal to or involving the occlusion)
Occluded ostium of the right coronary artery or stem of left main coronary artery as target lesion
Totally occluded bypass graft as target vessel
Occlusion in an unprotected left main coronary artery
Ejection fraction less than 30%
Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot traverse
Lesion within a bifurcation with a significant sidebranch >1.5mm in diameter
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| Name | Affiliation | Role |
|---|---|---|
| Projessor Patrick W. Serruys, PhD | Erasmus Medical University Thoraxcenter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC University Medical Center | Rotterdam | The Netherlands | Netherlands |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Assessed and measured during interventional procedure up to discharge-average hospital stay 1-5 days- defined in protocol as the number of days between interventional treatment and hospital discharge |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |