Rationale and Design of a Prospective, Multicenter, Single-Arm Clinical Trial to Investigate the Safety and Effectiveness of Rotablator Atherectomy System as an Adjunctive Device for Endovascular Treatment of Occlusive Atherosclerotic Lesions in Below-the-Knee Arteries With Critical Limb Ischemia (RESCUE-BTK)

Background: Endovascular treatment with balloon angioplasty plays a major role in revascularization of below-the-knee (BTK) arteries in patients with critical limb ischemia (CLI). However, with severely calcified lesions, achieving optimal revascularization with balloon angioplasty alone is difficult. Therefore, we are evaluating the safety and effectiveness of the Rotablator atherectomy system as an adjunctive device in the treatment of severely calcified lesions in BTK arteries in the RESCUE-BTK trial, a multicenter, single-arm, open-label, exploratory investigator-initiated clinical study of medical devices. In this paper we describe the design of the trial. Methods and Results: Seventeen patients with CLI in whom balloon angioplasty has failed are enrolled in the study. The primary endpoint is the procedural success rate of balloon angioplasty after rotational atherectomy. Success is defined as the fulfillment of 3 requirements upon assessment by the core laboratory: (1) final residual diameter stenosis <50%; (2) the absence of a delay in flow or vessel perforation in the target artery, or both; and (3) brisk antegrade flow to the foot. Key secondary endpoints are the number of complications associated with the trial procedures and the limb salvage rate. Participants are followed-up for 6 months after the trial procedures. Conclusions: The RESCUE-BTK trial will clarify the safety and effectiveness of the adjunctive use of the Rotablator system in severely calcified lesions of BTK arteries in patients with CLI.