Clinical trial NCT01131793: PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)
Official title: Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Chronic Total Occlusion In-Stent
Lead sponsor: Stereotaxis
Sponsor class: INDUSTRY
First posted: 2010-05-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Primary RF wire success
timeFrame: 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:
measure: Facilitated RF wire Success: Procedure Success: Clinical Success
timeFrame: 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
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Medical Center
state: The Netherlands
Study officials:
affiliation: Erasmus Medical University Thoraxcenter
name: Projessor Patrick W. Serruys, PhD
role: PRINCIPAL_INVESTIGATOR
References: