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

NCT01131793 | Completed Phase 2

• 1 other identifier: CLIN-019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Chronic Total Occlusion In-Stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Facilitated RF wire Success: Procedure Success: Clinical Success

  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

Study Arms (1)

RF Guidewire

EXPERIMENTAL

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

Interventions

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

Also known as: PowerAssert RF, Magnetic RF Wire

RF Guidewire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stereotaxis: lead

Study Sites (1)

Erasmus MC University Medical Center

Rotterdam, The Netherlands, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Projessor Patrick W. Serruys, PhD

  Erasmus Medical University Thoraxcenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 27, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

NL (1)