Impact of Tibial Run Off on Clinical Outcome of Endovascular Therapy in Femoropopliteal Lesions (… (NCT04675632) | Clinical Trial Compass
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
Sex
ALL
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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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Timeframe: 24 months
2
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