Primary Cryoplasty Therapy Provides Durable Support for Limb Salvage in Critical Limb Ischemia Patients with Infrapopliteal Lesions: 12-Month Follow-up Results from the BTK Chill Trial

Purpose:To report the 12-month follow-up data from the prospective 16-center Below-the-Knee (BTK) Chill Trial, which examined the use of primary cryoplasty for BTK occlusive disease in patients with critical limb ischemia (CLI).Methods:The trial included 108 patients (77 men; mean age 73±11 years, range 41–101) with CLI (Rutherford categories 4–6) involving 111 limbs with 115 target infrapopliteal lesions. Angiographic inclusion criteria were reference vessel diameter ≥2.5 mm and ≤5.0 mm and target lesion stenosis ≥50%. The primary study endpoints were acute technical success (the ability to achieve ≤50% residual stenosis and continuous inline flow to the foot) and absence of major amputation of the target limb at 6 months. Secondary endpoints were serious adverse events specifically related to use of primary cryoplasty and absence of major amputation of the target limb at 1, 3, and 12 months.Results:Acute technical success was achieved in 108 (97.3%) of treated limbs, with only 1 clinically significant d...