Dethrombosis of lower extremity arteries by local delivery of thrombolysis using the ClearWay transcatheter balloon irrigation system: a feasibility study

Nicolas W. Shammas; Neil J. Weissman; Denise Coiner; Gail A. Shammas; Michael Jerin; Lori Christensen

doi:10.1016/j.carrev.2011.04.252

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 ClearWayTM 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. Results Twenty consecutive patients were enrolled in this study (11 males, mean age 68.54±8.15 years). Based on patients' symptom onset, 1 patient was acute (<24 h), 4 subacute (>24 h, <30 days) and 15 chronic (between 1 and 6 months). There were no statistical difference in plaque/thrombus volume between baseline (pretreatment) and control ClearWay treatment (saline infusion) (P=.911, n=4). Also, there was no statistical difference in plaque/thrombus volume between pretreatment baseline and ClearWay tpA treatment (P=.628). Following Angiojet rheolytic thrombectomy (n=8 patients) post-ClearWay lytic treatment, there was a statistical reduction of plaque/thrombus volume vs. ClearWay lytic treatment alone (P=.03) or pretreatment baseline (P=.029). There were no deaths or amputations. Macrodebris >2 mm were present in 50% of patients captured by embolic filter protection. In-hospital reocclusion of the treated vessel occurred in one patient (5%), and 30-day reocclusion occurred in two patients (10%) on follow-up. Conclusion Using the ClearWay to deliver lytic therapy appears safe in this small feasibility study. Although lytic treatment with the ClearWay balloon alone did not demonstrate reduction in plaque/thrombus volume in this small population, the use of Angiojet rheolytic thrombectomy following ClearWay did reduce plaque volume. Further data are needed to address definitive effects of ClearWay balloon alone and utility to facilitate Angiojet thromboreduction.

Dethrombosis of lower extremity arteries by local delivery of thrombolysis using the ClearWay transcatheter balloon irrigation system: a feasibility study

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