To assess the clinical application and safety of the CleanerTM rotary thrombus removal system, a novel thrombus removal device, in iliac-femoral venous thrombosis (I-FVT).

In this study, 15 patients who were diagnosed with I-FVT by lower limb color Doppler ultrasonography and treated with the CleanerTM rotary thrombus removal system in the People's Hospital of Xinjiang Uygur Autonomous Region from March 2021 to February 2022 were included. The clinical data collected included preoperative and postoperative color ultrasound images, intraoperative images, circumference of both lower limbs (15 cm above and below the knee), perioperative complications, recurrence of thrombosis and post-thrombotic syndrome during follow-up, etc. Intraoperative imaging and lower limb color ultrasound were used to evaluate the patency of venous lumen and the reduction of the circumference difference between the affected and healthy limbs to evaluate the curative effect.

Among the 15 patients with I-FVT, 13 only received CleanerTM rotary thrombolectomy, and 2 had residual thromboclastic debris crushed by assisted large-diameter catheter aspiration. Angiography showed that 13 cases (86.7%) of grade Ⅲ thromboli and 2 cases (13.3%) of grade II were cleared, with an average blood loss of (28.0±15.2) ml. In 3 patients with left iliac vein stent implantation, no device-related adverse events, major bleeding, symptomatic pulmonary embolism, or other complications occurred. Forty-eight hours after surgery, both the limb circumference at 15 cm above the knee (5.07±2.18 cm vs 0.64±1.58 cm) and that below the knee (3.02±1.30 cm vs 0.52±0.89 cm) decreased significantly (P<0.05). There was no recurrence of thrombosis or PTS during the 24-month follow-up, and the average Villalta score was (1.33±0.23).

The percutaneous mechanical CleanerTM rotary thrombus removal system is a safe and effective thrombus removal method, which can be adapted to different diameters of lower limb venous lumen, quickly remove thrombus, reduce residual thrombus, and avoid the risks associated with catheter thrombolysis.