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

Coronary Artery Disease Clinical Trial

— TOTAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131793
• Other study ID #: CLIN-019
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2010
• Last updated: July 19, 2011
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2011
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus MC University Medical Center	Rotterdam	The Netherlands

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes