RecruitingNCT05620095

Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)

Sponsor

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

Enrollment

1,000 participants

Start Date

Dec 1, 2020

Study Type

OBSERVATIONAL

Conditions

Chronic Limb Threatening Ischemia Peripheral Artery Disease Arteriosclerosis

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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.
Life expectancy\> 24 months.

Exclusion Criteria7

Blood flow was not successfully reestablished.
Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
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

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