Trials / Completed
CompletedNCT01131793
PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)
Total Occlusion With Angioplasty After Using a Radiofrequency Guide Wire-Magnetic-Coronary
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Stereotaxis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2010-05-27
- Last updated
- 2011-07-20
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01131793. Inclusion in this directory is not an endorsement.