PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)

Study Overview
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Brief Summary
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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

Detailed Description
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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 Event free survival Anginal status, and Target vessel patency minimal luminal diameter (MLD).

Official Title
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Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: PowerAssert RF wire in crossing coronary in-stent chronic total occlusions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligible for elective revascularization of a native coronary vessel Patient has refractory coronary total occlusion (Thrombolysis In Myocardial Infarction (TIMI) 0 flow) within a stent Written Informed Consent obtained 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

Ages Eligible for Study
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Minimum Age: 18 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RF Guidewire<br> | Device: PowerAssert RF wire in crossing coronary in-stent chronic total occlusions<br>* 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<br>* Other names: Magnetic RF Wire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Chronic Total Occlusion In-Stent