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Impact of Tibial Run Off on Clinical Outcome of Endovascular Therapy in Femoropopliteal Lesions (TALENT Study)

Chengdu University of Traditional Chinese Medicine · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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This study is a prospective, multicenter, real world, observational study intended to understand the impact of tibial run off on clinical outcome of endovascular therapy in Femoropopliteal lesions. It is estimated that 1200 patients with chronic femoral popliteal artery occlusion were enrolled in the group at 8 centers nationwide from January 2021 to December 2022. Two groups would be divided according to whether or not the tibial run off intervened for reconstruction. The intervention group and the non-intervention group. The intervention group would be evaluated Run-off score again after the tibial run off reconstructed. The the Society for Vascular Surgery(SVS) run-off score would be used for the score of the tibial run off. The total score of the tibial run off would be 19 points, 1 point indicating healthy run off. According to the quality of the run off, the preoperative patients would be divided into 1-5, 6-10, 11-15, and \>15 points. The follow-up would be conducted at 1, 6, 12, 18 and 24 months after the operation. As it is a real world study, there is no determined end point.The main indicators would be observed including the reintervention rate driven by lesions' clinical symptoms, the rate of primary patency of the femoral popliteal artery, the improvement of quality of life score and rutherford grading.
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