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Completed

NCT Number: NCT01131793

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

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erasmus MC University Medical Center

Rotterdam, The Netherlands, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other names: PowerAssert RF, Magnetic RF Wire

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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

Sponsors and collaborators

Lead sponsor

Stereotaxis

Industry

Registry information

Official study title

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

Acronym: TOTAR

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 27, 2010
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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