Pilot Study to Determine Safety and Efficacy of Paclitaxel Infusion in De Novo Peripheral Lesions Using the Atrium ClearWay Balloon.

Objective: To evaluate the safety and efficacy of a one-time infusion of paclitaxel through an Atrium ClearWay balloon in infra inguinal de novo peripheral lesions.

Methods: This is a single-center prospective study looking at treatment of 50 limbs. Treatment includes standard infra inguinal endovascular revascularization followed by a pre-prescribed infusion of paclitaxel. Control is standard reintervention without subsequent paclitaxel infusion. Patients were followed at one, four, and 10 months with ankle-brachial index (ABI)s, arterial duplex of the treated limb, and Rutherford classification stage measured before and after procedures and at each follow-up. Freedom from binary restenosis was tracked with duplex ultrasound, and freedom from target lesion revascularization (TLR) was also tracked in the treatment group. Binary restenosis and TLR data was harvested from the patient record for the control group.

Results: Average ABI and Rutherford classification stage improved as expected. The treatment group had a freedom from TLR rate of 86 percent and a freedom from binary restenosis rate of 80 percent at 10 months. Average ABI improved from 0.65 at baseline to 0.94 at 10 months in the treatment group. The control group had a 72 percent freedom from TLR and a 58 percent freedom from binary restenosis at 10 months. Average ABI of the control group improved from 0.67 at baseline to 0.85 at 10 months in the control group. There were no amputations, open bypass revascularizations, or hypersensitivity reactions observed in the treatment group.

Conclusions: Infusion of paclitaxel in de novo lesions appears to be a safe and efficacious treatment in the peripheral vasculature when compared to a historical control group. While it is early, it appears that the patients do receive some benefit from this one time infusion, and this approach should be studied further.