Status:
COMPLETED
Impact of Tibial Run Off on Clinical Outcome of Endovascular Therapy in Femoropopliteal Lesions (TALENT Study)
Lead Sponsor:
Chengdu University of Traditional Chinese Medicine
Conditions:
Femoropopliteal Artery Occlusion
Eligibility:
All Genders
Brief 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...
Detailed Description
Arteriosclerosis obliterans of lower extremities (arteriosclerosis obliterans, ASO) is a common and frequently-occurring disease in middle-aged and elderly people, and also an important manifestation ...
Eligibility Criteria
Inclusion
- 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
- 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), other anticoagulant or antiplatelet therapies, and/or paclitaxel.
- 6\) Patients with bleeding constitution. 7) Pregnant and lactating women. 8) Patients with a history of myocardial infarction or unstable angina within 3 months.
- 9\) Patients with a history of TIA or cerebral infarction within 3 months. 10) Patients with severe disease such as liver failure. 11) Patients with a life expectancy of less than 24 months. 12) Participating in other drug or device studies currently. 13) Patients with poor treatment compliance or deemed unsuitable for inclusion in the group by the researcher.
Key Trial Info
Start Date :
January 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04675632
Start Date
January 4 2021
End Date
June 30 2025
Last Update
August 3 2025
Active Locations (1)
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1
Chunshuihe
Chengdu, Sichuan, China, 610000