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Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system
Roberto Gandini1, Tommaso Volpi, Vincenzo Pipitone
1Department of Diagnostic and Molecular Imaging, University of Rome Tor Vergata, Rome, Italy.
Insights
The Crosser CTO Recanalization System safely and effectively opened long blocked leg arteries in 75% of patients, reducing procedure time for chronic total occlusions (CTO). This vibrational angioplasty device shows promise for critical limb ischemia treatment.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomedical Engineering
Background:
- Chronic total occlusions (CTO) in the infrainguinal arteries often lead to critical limb ischemia.
- Conventional guidewire techniques have limited success in recanalizing long CTOs.
- Novel devices are needed to improve recanalization rates and reduce procedural times.
Purpose of the Study:
- To evaluate the safety and efficacy of the Crosser CTO Recanalization System.
- To assess its performance in percutaneous intraluminal recanalization of long infrainguinal CTOs.
- To determine its utility in patients with critical limb ischemia resistant to conventional methods.
Main Methods:
- The Crosser CTO Recanalization System utilizes high-frequency vibrational energy to navigate fibrocalcific plaque.
- A prospective study was conducted on 12 diabetic patients with long infrainguinal CTOs.
- The device was used in cases resistant to standard guidewire techniques.
Main Results:
- The Crosser system successfully crossed the CTO in 9 out of 12 patients (75%) within 5 minutes.
- The mean crossing time was 4 minutes and 3 seconds.
- The safety endpoint, defined as no vessel perforation or dissection, was achieved in all successful recanalizations.
Conclusions:
- The Crosser CTO Recanalization Catheter demonstrated a high rate of successful intraluminal recanalization for long infrainguinal CTOs.
- The device proved to be safe in this preliminary patient cohort.
- It significantly decreased procedural crossing time, offering a potential advancement in treating complex arterial occlusions.
Purpose:
To assess the safety and efficacy of a device for vibrational angioplasty in the percutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO).
Technique:
The Crosser CTO Recanalization System is a mechanical recanalization device that uses high-frequency vibrational energy to disrupt and channel through fibrocalcific plaque without harming the vessel wall, thus assisting in the recanalization of an occluded artery. In 12 diabetic patients (7 men; median age 71 years, range 58-80) with critical limb ischemia owing to long (median length 26 cm, range 21-32) infrainguinal CTOs resistant to conventional guidewire techniques, the Crosser CTO Recanalization System was successful in intraluminally crossing the occlusion in 9 (75%) patients in <5 minutes (mean 4:03 minutes). The safety endpoint (distal lumen guidewire position with no vessel perforation or dissection) was achieved in all successful cases.
Conclusion:
In our preliminary experience, the Crosser CTO Recanalization Catheter decreased crossing time, was safe, and achieved a high rate of intraluminal recanalization of long infrainguinal CTOs.