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).
Patients with critical limb ischemia (Rutherford category 4-6) 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.
Study Type
OBSERVATIONAL
Enrollment
1,000
To evaluate the effectiveness and safety of drug-coated balloon angioplasty for infrapopliteal artery lesions in patients with CLTI.
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGZibo Feng
Wuhan, Hubei, China
RECRUITINGPrimary sustained clinical improvement at 12 months post-procedure
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.
Time frame: 12 months
Freedom of major limb adverse events at 12 months post-procedure
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.
Time frame: 12 months
Patency of the target lesions at 1 month, 3 months, 6 months and 12 months post-interventional
Patency includes the absence of clinically driven target lesion revascularization and/or recurrent target lesion diameter stenosis ≥50% by imaging (e.g., invasive angiography or, most commonly, duplex ultrasonography).
Time frame: 1 month, 3 months, 6 months, 12 months
Procedural success rate
Procedural success for peripheral revascularization is defined as both technical success and absence of major adverse events (e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.
Time frame: 72 hours
Vascular quality of life questionnaire(VascuQol)
The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life. 1 month, 3 months, 6 months, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
the second Affiliated Hospital of Medical College of Suzhou University
Suzhou, Jiangsu, China
RECRUITINGQingdao Haici hospital affiliated to Qingdao University
Qingdao, Shandong, China
RECRUITINGHuashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGRenji Hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
RECRUITINGZhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGHospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
RECRUITINGHangzhou First People's hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGthe First Affiliated hospital of Medicine College of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGTime frame: 1 month, 3 months, 6 months, 12 months
Wound healing rate
Wound healing in patients with Rutherford grade 5.
Time frame: 1 month, 3 months, 6 months, 12 months
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at 1 month, 3 months, 6 months, 12 months post-procedure.
Clinically driven target lesion revascularization is defined as target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed.
Time frame: 1 month, 3 months, 6 months, 12 months
Major adverse events at 1 month, 3 months, 6 months, 12 months post-procedure.
Death, unplanned major amputation of the target limb, and CD-TLR were defined as a major adverse event.
Time frame: 1 month, 3 months, 6 months, 12 months
Amputation free survival rate
Amputation free survival rate after surgery.
Time frame: 1 month, 3 months, 6 months, 12 months
Primary sustained clinical improvement
Percentage of participants that experienced primary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.
Time frame: 1 month, 3 months, 6 months
Secondary sustained clinical improvement
Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects.
Time frame: 1 month, 3 months, 6 months, 12 months