Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection

Exclusion Criteria

• •1. The target lesion has been stented or previously treated with bypass surgery
• •2. Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
• •3. Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
• •4. More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
• •5. The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
• •6. Planned amputation on the target limb
• •7. Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
• •8. Uncontrollable infections
• •9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
• •10. Participating in clinical trials of any other drug or medical device and not yet out of the study
• •11. Other circumstances not suitable for inclusion as judged by the investigator