Recanalization of infrainguinal chronic total occlusions with the crosser system: results of the PATRIOT trial.

PURPOSE: To evaluate the angiographic and functional outcomes of the Crosser chronic total occlusion (CTO) recanalization system used to facilitate crossing of infrainguinal occlusions resistant to conventional guidewire techniques. METHODS: Eighty-five patients with a previous or concurrent failed attempt to cross a CTO using conventional guidewire techniques were enrolled at eight United States centers. Occlusions were at least 30 days old and ≤30 cm in length. Primary endpoints included advancement of the recanalization system into or through the occlusion gaining guidewire access in the distal vessel beyond the lesion, and 30-day freedom from clinical perforation requiring treatment. RESULTS: The average age of occlusion was 16 months, the mean occlusion length was 117.5 ± 84.0 mm, 55.7% had unfavorable morphology for crossing, and 75% were moderately to severely calcified. Superficial femoral artery (SFA) occlusions were most commonly treated (61.2%), followed by popliteal artery (20%), and tibioperoneal (16.5%) occlusions. The CTO was crossed and the guidewire successfully advanced into the distal true lumen in 83.5% of cases. Following adjunctive therapy, 81.2% achieved a satisfactory angiographic result (≤50% residual stenosis). At 30 days post procedure, 98.8% of patients were free from clinical perforation. CONCLUSION: Use of the Crosser CTO recanalization system facilitated crossing of guidewire-resistant, chronic, infrainguinal occlusions with minimal risk of clinically significant vessel perforation.