CompletedNot Applicable

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

China1,200 participantsStarted 2021-01-04

Plain-language summary

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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\) Rutherford stages 2-5. 2) The femoral and popliteal artery as the target of the study has at least ≥70% stenosis or occlusion. 3\) Whether it is a primary femoral and popliteal artery disease or in-stent restenosis, patients who received endovascular recanalization successfully (Residual stenosis \<30% and no flow-limiting arterial dissection) can be enrolled in the group. 4\) For the patients with both lower limbs to be treated, both limbs can be selected into the group. 5\) Patients who failed the first treatment because the guide wire could not pass through the lesion can still be included in the group after successful endovascular interventional treatment. 6\) Patients who understand the purpose of this research, volunteer to participate in the experiment, sign an informed consent form and are willing to be followed up can be included in the experiment. 7\) For ipsilateral aortoiliac artery disease, patients with residual stenosis \<30% can also be included in the group after intravascular reconstruction. Exclusion Criteria: * 1\) Patients with acute arterial thrombosis. 2) Patients with serum creatinine level\> 176μmol/L. 3) Patients with Rutherford stage 5 have foot infection grades of 2 and 3 in the preoperative WIFI (WIfI) classification. 4\) Limbs that have been treated with the femoral and popliteal artery bypass surgery. 5\) Patients who are known to be allergic or sensitive to contrast agents, heparin, aspirin (ASA…

What they're measuring

the clinically driven target lesion revascularization(CD-TLR) rate at post-interventional

Timeframe: 24 months

Changes of the patency rate of target(Femoropopliteal) lesions at post-interventional

Timeframe: baseline and 24 months

Trial details

NCT IDNCT04675632

SponsorChengdu University of Traditional Chinese Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Femoropopliteal Artery Occlusion trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.