A Phase 2 interventional study of PowerAssert RF wire in crossing coronary in-stent chronic total occlusions in Coronary Artery Disease, sponsored by Stereotaxis. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-20.
Sponsored by Stereotaxis · Phase 2, Interventional, and Treatment
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
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 5 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Stereotaxis is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Current participation in another study with any investigational drug or device
->TIMI 0 flow at target lesion site
Device: PowerAssert 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
Also known as: PowerAssert RF, Magnetic RF Wire
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)
Time frame: 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: 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
Time frame: 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
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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