Back to resultsPowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO) (TOTAR)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
PowerAssert RF wire in crossing coronary in-stent chronic total occlusions
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Chronic Total Occlusion In-Stent
Eligibility Criteria
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
Sites / Locations
- Erasmus MC University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RF Guidewire
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01131793
Brief Title
PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)
Acronym
TOTAR
Official Title
Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stereotaxis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Chronic Total Occlusion In-Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RF Guidewire
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PowerAssert RF wire in crossing coronary in-stent chronic total occlusions
Other Intervention Name(s)
PowerAssert RF, Magnetic RF Wire
Intervention Description
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
Primary Outcome Measure Information:
Title
Primary RF wire success
Description
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 Outcome Measure Information:
Title
Facilitated RF wire Success: Procedure Success: Clinical Success
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Projessor Patrick W. Serruys, PhD
Organizational Affiliation
Erasmus Medical University Thoraxcenter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC University Medical Center
City
Rotterdam
State/Province
The Netherlands
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)
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