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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: PowerAssert RF wire in crossing coronary in-stent chronic total occlusions

• Registration Number: NCT01131793
• Lead Sponsor: Stereotaxis

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).

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-27
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RF Guidewire	PowerAssert RF wire in crossing coronary in-stent chronic total occlusions	-

Primary Outcome Measures

Name	Time	Method
Primary RF wire 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	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

Name	Time	Method
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	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

Trial Locations

Locations (1)

Erasmus MC University Medical Center; 🇳🇱 Rotterdam, The Netherlands, Netherlands