Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
China1,000 participantsStarted 2020-12-01
Plain-language summary
This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Rutherford grade 4-6.
✓. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
✓. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries \>20 mm. Lesions should not extend beyond the ankle joint.
✓. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow.
✓. At least one of the infrapopliteal arteries received a drug-coated balloon.
✓. For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%.
✓. In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention.
✓. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
Exclusion criteria
✕. Blood flow was not successfully reestablished.
✕. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
What they're measuring
1
Primary sustained clinical improvement at 12 months post-procedure
Timeframe: 12 months
2
Freedom of major limb adverse events at 12 months post-procedure
Timeframe: 12 months
Trial details
NCT IDNCT05620095
SponsorLiyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
✕. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
✕. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
✕. Pregnant and lactating women.
✕. Patients with Berg's disease.
✕. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia