Coronary Artery Disease
Conditions
Keywords
Coronary Artery Chronic Total Occlusion In-Stent
Brief summary
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
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).
Interventions
DEVICEPowerAssert RF wire in crossing coronary in-stent chronic total occlusions
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
Sponsors
Stereotaxis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary RF wire success | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Facilitated RF wire Success: Procedure Success: Clinical Success | 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 | 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 |
Countries
Netherlands
Outcome results
None listed