Background
Thrombus is highly prevalent in patients with recent symptoms (<6 months) of claudication or limb ischemia and occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the Vascular ClearWay TM Irrigating PTFE Balloon Catheter (Atrium) has been tested for its safety and ability to dissolve thrombus in patients with recent arterial occlusions.
Methods
Volumetric core lab assessment of the thrombus was performed at baseline and after ClearWay thrombolysis but prior to definitive treatment of the vessel to evaluate thrombus resolution. Twenty consecutive patients were prospectively enrolled. Four controls and 10 study subjects treated with tPA (doses from 0.25 mg/cm to 0.6 mg/cm of treated occlusion; eight patients treated with Angiojet following ClearWay treatment) had interpretable intravascular ultrasound images by the core lab blind to sequence and free of calcium, allowing volumetric analysis.
Methods
Volumetric core lab assessment of the thrombus was performed at baseline and after ClearWay thrombolysis but prior to definitive treatment of the vessel to evaluate thrombus resolution. Twenty consecutive patients were prospectively enrolled. Four controls and 10 study subjects treated with tPA (doses from 0.25 mg/cm to 0.6 mg/cm of treated occlusion; eight patients treated with Angiojet following ClearWay treatment) had interpretable intravascular ultrasound images by the core lab blind to sequence and free of calcium, allowing volumetric analysis.
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