An observational study in Arteriosclerosis, Peripheral Artery Disease and Chronic Limb Threatening Ischemia, sponsored by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · Observational
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.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Compared within Chronic Limb-Threatening Ischemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arteriosclerosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients suffered with Chronic Limb Theratening Ischemia and with significant infrapopliteal artery lesions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To evaluate the effectiveness and safety of drug-coated balloon angioplasty for infrapopliteal artery lesions in patients with CLTI.
Primary 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
Time 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
Plan to share: No
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Chronic Limb-Threatening Ischemia →
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology