Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство drug-coated balloon
  To evaluate the effectiveness and safety of drug-coated balloon angioplasty for infrapopliteal artery lesions in patients with CLTI.

Первичные конечные точки

• Primary sustained clinical improvement at 12 months post-procedure [Срок оценки: 12 months]
• Freedom of major limb adverse events at 12 months post-procedure [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Patency of the target lesions at 1 month, 3 months, 6 months and 12 months post-interventional [Срок оценки: 1 month, 3 months, 6 months, 12 months]
• Procedural success rate [Срок оценки: 72 hours]
• Vascular quality of life questionnaire(VascuQol) [Срок оценки: 1 month, 3 months, 6 months, 12 months]
• Wound healing rate [Срок оценки: 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. [Срок оценки: 1 month, 3 months, 6 months, 12 months]
• Major adverse events at 1 month, 3 months, 6 months, 12 months post-procedure. [Срок оценки: 1 month, 3 months, 6 months, 12 months]
• Amputation free survival rate [Срок оценки: 1 month, 3 months, 6 months, 12 months]
• Primary sustained clinical improvement [Срок оценки: 1 month, 3 months, 6 months]
• Secondary sustained clinical improvement [Срок оценки: 1 month, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 10 центров

• Xuanwu Hospital Capital Medical University — Пекин
• Zibo Feng — Ухань
• the second Affiliated Hospital of Medical College of Suzhou University — Сучжоу
• Qingdao Haici hospital affiliated to Qingdao University — Qingdao
• Huashan Hospital, Fudan University — Шанхай
• Renji Hospital of Shanghai Jiaotong University — Шанхай
• Zhongshan Hospital of Fudan University — Шанхай
• Hospital of Chengdu University of Traditional Chinese Medicine — Чэнду
• … и ещё 2 центра

Идентификаторы

NCT: NCT05620095 · the Act study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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