LumenRECON Guidewire: Pilot Study of a Novel, Nonimaging Technology for Accurate Vessel Sizing and Delivery of Therapy in Femoropopliteal Disease.
Circ Cardiovasc Interv
; 11(1): e005333, 2018 01.
Article
in En
| MEDLINE
| ID: mdl-29311285
ABSTRACT
BACKGROUND:
Proper vessel sizing during endovascular interventions is crucial to avoid adverse procedural and clinical outcomes. LumenRECON (LR) is a novel, nonimaging, 0.035-inch wire-based technology that uses the physics-based principle of Ohm's law to provide a simple, real-time luminal size while also providing a platform for therapy delivery. This study evaluated the accuracy, reliability, and safety of the LR system in patients presenting for a femoropopliteal artery intervention. METHODS ANDRESULTS:
This multicenter, prospective pilot study of 24 patients presenting for peripheral intervention compared LR measurements of femoropopliteal artery size to angiographic visual estimation, duplex ultrasound, quantitative angiography, and intravascular ultrasound. The primary effectiveness and safety end point was comparison against core laboratory adjudicated intravascular ultrasound values and major adverse events, respectively. Additional preclinical studies were also performed in vitro and in vivo in swine to determine the accuracy of the LR guidewire system. No intra- or postprocedure device-related adverse events occurred. A balloon or stent was successfully delivered in 12 patients (50%) over the LR wire. Differences in repeatability between successive LR measurements was 2.5±0.40% (R2=0.96) with no significant bias. Differences in measurements of LR to other modalities were 0.5±1.7%, 5.0±1.8%, -1.5±2.0%, and 6.8±3.4% for intravascular ultrasound core laboratory, quantitative angiography, angiographic, and duplex ultrasound, respectively.CONCLUSIONS:
This study demonstrates that through a physics-based principle, LR provides a real-time, safe, reproducible, and accurate vessel size of the femoropopliteal artery during intervention and can additionally serve as a conduit for therapy delivery over its wire-based platform.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Popliteal Artery
/
Catheterization, Peripheral
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Femoral Artery
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Peripheral Arterial Disease
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Endovascular Procedures
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Vascular Access Devices
Type of study:
Clinical_trials
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Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Aged
/
Animals
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Female
/
Humans
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Male
/
Middle aged
Country/Region as subject:
America do norte
Language:
En
Journal:
Circ Cardiovasc Interv
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
Year:
2018
Document type:
Article