Rationale And Objectives: The objective of this study was to evaluate the safety and the effectiveness of the Outback catheter for intraluminal re-entry after subintimal dissection in the crossing of chronic arterial occlusions.
Methods: This study was a proof-of-concept feasibility. Ten patients with totally occluded arteries in the iliac artery to the distal femoral artery (mean occlusion length, 13.1 cm; range, 5-25 cm) were treated with the novel catheter. After successful re-entry, PTA or PTA plus stenting was performed.
Results: No perforations, dissections, lacerations, or device complications occurred. The procedural re-entry success rate with the Outback catheter was 50% (5/10 patients).
Conclusions: Although the Outback catheter is safe, the percentage of intraluminal reaccess should be ameliorated through engineering improvements because there is some evidence to suggest that subintimal recanalization could produce improved long-term results.
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