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

Stereotaxis5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

PowerAssert RF wire in crossing coronary in-stent chronic total occlusionsDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Erasmus MC University Medical Center

Rotterdam, The Netherlands, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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