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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

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

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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).

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RF Guidewire

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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PowerAssert RF Magnetic RF Wire

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No