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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: PowerAssert RF wire in crossing coronary in-stent chronic 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).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • The Netherlands
    • Rotterdam, The Netherlands, Netherlands
      • Erasmus MC University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RF Guidewire	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; Other Names: PowerAssert RF; Magnetic RF Wire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stereotaxis
• Investigators: Principal Investigator: Projessor Patrick W. Serruys, PhD, Erasmus Medical University Thoraxcenter

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Coronary Artery Chronic Total Occlusion In-Stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CLIN-019