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

This study has been completed.
Sponsor:
Information provided by:
Stereotaxis
ClinicalTrials.gov Identifier:
NCT01131793
First received: May 20, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
 Device: PowerAssert RF wire in crossing coronary in-stent chronic total occlusions
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stereotaxis:

Primary Outcome Measures:
  • Primary RF wire success [ 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 ] [ Designated as safety issue: Yes ]
    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 [ 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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 5
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131793

Locations
Netherlands
Erasmus MC University Medical Center
Rotterdam, The Netherlands, Netherlands
Sponsors and Collaborators
Stereotaxis
Investigators
Principal Investigator: Projessor Patrick W. Serruys, PhD Erasmus Medical University Thoraxcenter
  More Information

No publications provided

Responsible Party: Mark Jacob, Stereotaxis Inc
ClinicalTrials.gov Identifier: NCT01131793     History of Changes
Other Study ID Numbers: CLIN-019
Study First Received: May 20, 2010
Last Updated: July 19, 2011
Health Authority: Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Stereotaxis:
Coronary Artery Chronic Total Occlusion In-Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013