Author: Dr. Yvonne Bausback
Institution: Berlin-Brandenburg Vascular Center, Evangelical Hubertus Hospital, Berlin, Germany
Summary
This study presents preliminary results on the use of the Rotarex® mechanical thrombectomy system in treating femoro-popliteal chronic total occlusions (CTO). The Rotarex system, designed for effective thrombus removal and revascularization, achieved high technical success rates and demonstrated good safety outcomes in the treatment of CTOs.
Study Design and Primary Endpoints
• Study Design: A retrospective single-center study including 25 patients (26 limbs) with femoro-popliteal CTO (occlusion >3 months), with an average follow-up period of 161 days. The primary objectives were to assess technical success, complication rates, and revascularization outcomes.
• Primary Endpoints: The study focused on major adverse events (MAE) within 30 days and target lesion revascularization (TLR) during follow-up. Results showed no MAE within 30 days, and the technical success rate reached 100%.
Study Results
• Initial Revascularization Rate: Rotarex demonstrated high efficiency in thrombus removal for CTOs. All patients achieved revascularization after one or multiple passes, with no severe complications such as stent fracture or vessel perforation.
• Long-Term Patency Rate: Six-month follow-up data indicated an initial patency rate of 87%, with four patients (26%) experiencing restenosis or re-occlusion.
Clinical Application and Conclusion
1. The Rotarex system demonstrates high technical success and a low complication rate in the initial treatment of femoro-popliteal CTOs, making it a suitable option for patients needing revascularization.
2. Preliminary follow-up data show good patency rates and low restenosis rates, with further studies needed to confirm long-term effectiveness.
3. The design of the Rotarex system effectively reduces embolization risk in occlusive lesions, providing a safe and efficient revascularization solution for femoro-popliteal CTO patients.
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