BD has announced plans to initiate a patient data registry for the Rotarex atherectomy system to measure real-world outcomes for patients with peripheral arterial disease (PAD).
Known as XTRACT, this prospective, multicentre, single-arm, post-market registry study will assess the clinical performance of the Rotarex atherectomy system in the treatment of US patients with PAD lesions. The XTRACT Registry is being led in partnership with co-principal investigators, Prakash Krishnan (Mount Sinai, New York, USA), an interventional cardiologist, and Todd Berland (NYU Langone Health, New York, USA), a vascular surgeon. The registry will enrol up to 600 patients at approximately 100 clinical sites across the USA, with the first patient enrolment expected later this year. Clinical follow-up evaluations will occur after 30 days, six months and 12 months post-procedure to assess safety and effectiveness of outcomes.
“This registry will provide valuable data to support clinical decision-making and enhance patient outcomes in the management of PAD,” said Krishnan. “The Rotarex system has been extensively studied internationally, and we are excited to further evaluate its adaptability in treating a wide range of PAD lesions within the US patient population.”
The Rotarex atherectomy system is a minimally invasive solution designed to efficiently remove both plaque and thrombus in peripheral arteries. Offering dual indications as both an atherectomy and thrombectomy device, the Rotarex atherectomy system is a proven tool for treating PAD.
“The XTRACT registry is the first comprehensive registry aimed at providing key insights into the real-world applications of the Rotarex system,” said Rima Alameddine, worldwide president of BD Interventional-Peripheral Intervention. “This study underscores our unwavering commitment to optimising treatment strategies in partnership with leading physicians to improve patient care.”
