Clinical experience with the OptiMed sinus stent in the peripheral arteries

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Biomedical Engineering

Background:

• Peripheral arterial occlusive disease (PAOD) significantly impacts patient quality of life.
• Nitinol self-expanding stents offer potential advantages in treating complex arterial lesions.
• Evaluating new stent technologies is crucial for improving treatment outcomes in PAOD.

Purpose of the Study:

• To assess the efficacy and safety of the novel Sinus self-expanding nitinol stent.
• To evaluate the performance of the Sinus stent in treating diverse lower limb arterial occlusive lesions.
• To compare outcomes between stenoses and occlusions treated with the Sinus stent.

Main Methods:

• Retrospective analysis of 403 lower limb lesions in 315 patients treated with the Sinus stent.
• Stenting included iliac, femoral, and popliteal arteries with varying degrees of stenosis and occlusion.
• Patient data included Fontaine classification, lesion characteristics, and procedural details.

Main Results:

• 100% technical success and 98% clinical success rates were achieved.
• Primary and secondary patency rates at 3 years were 72.5% and 81.8%, respectively.
• Stenoses showed significantly better patency than occlusions (p<0.001); lesion length >8 cm in occlusions led to higher restenosis.

Conclusions:

• The Sinus stent is a safe and effective option for treating peripheral arterial occlusive diseases.
• Excellent outcomes were observed at the iliac and common femoral artery levels.
• Optimal results are achieved for stenoses over occlusions, with lesion length