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Recruiting NCT05620095

Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

— Observational Arteriosclerosis Peripheral Artery Disease Chronic Limb Threatening Ischemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: drug-coated balloon.
Who it may be relevant to
Registry conditions: Arteriosclerosis, Peripheral Artery Disease, Chronic Limb Threatening Ischemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 4-6) 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.

Interventions

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

Primary outcome measures

  • Primary sustained clinical improvement at 12 months post-procedure [Time frame: 12 months]
  • Freedom of major limb adverse events at 12 months post-procedure [Time frame: 12 months]
Secondary outcome measures (9)
  • Patency of the target lesions at 1 month, 3 months, 6 months and 12 months post-interventional [Time frame: 1 month, 3 months, 6 months, 12 months]
  • Procedural success rate [Time frame: 72 hours]
  • Vascular quality of life questionnaire(VascuQol) [Time frame: 1 month, 3 months, 6 months, 12 months]
  • Wound healing rate [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. [Time frame: 1 month, 3 months, 6 months, 12 months]
  • Major adverse events at 1 month, 3 months, 6 months, 12 months post-procedure. [Time frame: 1 month, 3 months, 6 months, 12 months]
  • Amputation free survival rate [Time frame: 1 month, 3 months, 6 months, 12 months]
  • Primary sustained clinical improvement [Time frame: 1 month, 3 months, 6 months]
  • Secondary sustained clinical improvement [Time frame: 1 month, 3 months, 6 months, 12 months]

Eligibility criteria

Inclusion criteria

  • 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 10 centers
  • Xuanwu Hospital Capital Medical University — Beijing
  • Zibo Feng — Wuhan
  • the second Affiliated Hospital of Medical College of Suzhou University — Suzhou
  • Qingdao Haici hospital affiliated to Qingdao University — Qingdao
  • Huashan Hospital, Fudan University — Shanghai
  • Renji Hospital of Shanghai Jiaotong University — Shanghai
  • Zhongshan Hospital of Fudan University — Shanghai
  • Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu
  • … and 2 more centers

Identifiers

NCT: NCT05620095 · the Act study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗