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 > or = 2.

Cryoplasty therapy for limb salvage in patients with critical limb ischemia.

Purpose: To report the 6-month outcomes from a prospective multicenter study investigating the use of cryoplasty (cold balloon angioplasty) to treat below-knee occlusive disease in patients with critical limb ischemia (CLI).

Methods: Between August 2004 and October 2005, 108 patients (77 men; mean age 73+/-12 years, range 41-101) with CLI involving 111 limbs were enrolled in a prospective multicenter trial (Below-the-Knee Chill Study), which was conducted at 16 institutions. The primary study endpoints were acute technical success, defined as the ability to achieve < or =50% residual stenosis and continuous inline flow to the foot, and absence of major (above or below-knee) amputation of the target limb 180 days post procedure.