Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arteriosclerosis
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Enrollment
- 1000
- Locations
- 10
- Primary Endpoint
- Primary sustained clinical improvement at 12 months post-procedure
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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).
Detailed Description
Patients with critical limb ischemia (Rutherford category 4-5) and significant infrapopliteal lesions appropriate for angioplasty will be enrolled in this study. Subjects will be treated with the AcoArt drug coated balloon, then follow-up will be conducted at 1, 3, 6, 12 months after index procedure. Data on wound, ischemia, foot infection (WIfI) calcifications, clinical improvements, wound healing, freedom form target- lesion revascularization, patency of the target lesion and major adverse events will be collected.
Investigators
Zibo Feng
Director of Vascular Surgery, Liyuan Hospital
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility Criteria
Inclusion Criteria
- •Rutherford grade 4-
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Primary sustained clinical improvement at 12 months post-procedure
Time Frame: 12 months
Primary sustained clinical improvement was defined as an upward shift on the Rutherford classification (Appendix) to a level of intermittent claudication without the need for repeated TLR in surviving patients without the need for unplanned amputation.
Freedom of major limb adverse events at 12 months post-procedure
Time Frame: 12 months
Major limb adverse events were defined as the composite of clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and treatment caused death.
Secondary Outcomes
- Amputation free survival rate(1 month, 3 months, 6 months, 12 months)
- Patency of the target lesions at 1 month, 3 months, 6 months and 12 months post-interventional(1 month, 3 months, 6 months, 12 months)
- Vascular quality of life questionnaire(VascuQol)(1 month, 3 months, 6 months, 12 months)
- Secondary sustained clinical improvement(1 month, 3 months, 6 months, 12 months)
- Procedural success rate(72 hours)
- Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at 1 month, 3 months, 6 months, 12 months post-procedure.(1 month, 3 months, 6 months, 12 months)
- Major adverse events at 1 month, 3 months, 6 months, 12 months post-procedure.(1 month, 3 months, 6 months, 12 months)
- Primary sustained clinical improvement(1 month, 3 months, 6 months)
- Wound healing rate(1 month, 3 months, 6 months, 12 months)