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

Stereotaxis

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131793

CLIN-019

Details and patient eligibility

About

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

Full 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).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

RF Guidewire

Experimental group

Treatment:

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