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NCT Number: NCT05620095

Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

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).

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Key information

Conditions

Arteriosclerosis Arterial Occlusive Diseases Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb Threatening Ischemia Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug-coated Balloon

Device

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

Primary outcomes

  1. 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.

  2. 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

  1. 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

    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).

  2. Procedural success rate

    Time frame: 72 hours

    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.

  3. Vascular quality of life questionnaire(VascuQol)

    Time frame: 1 month, 3 months, 6 months, 12 months

    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

  4. Wound healing rate

    Time frame: 1 month, 3 months, 6 months, 12 months

    Wound healing in patients with Rutherford grade 5.

  5. 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

    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.

  6. Major adverse events at 1 month, 3 months, 6 months, 12 months post-procedure.

    Time frame: 1 month, 3 months, 6 months, 12 months

    Death, unplanned major amputation of the target limb, and CD-TLR were defined as a major adverse event.

  7. Amputation free survival rate

    Time frame: 1 month, 3 months, 6 months, 12 months

    Amputation free survival rate after surgery.

  8. Primary sustained clinical improvement

    Time frame: 1 month, 3 months, 6 months

    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.

  9. Secondary sustained clinical improvement

    Time frame: 1 month, 3 months, 6 months, 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ye Du

CONTACT

[email protected]

86-15827105515

Zibo Feng

CONTACT

[email protected]

86-13545160302

Sponsors and collaborators

Lead sponsor

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

Other

Collaborators

  • Chengdu University of Traditional Chinese Medicine
  • First People's Hospital of Hangzhou
  • Huashan Hospital
  • Qingdao University
  • RenJi Hospital
  • Second Affiliated Hospital of Suzhou University
  • Shanghai Zhongshan Hospital
  • Xuanwu Hospital, Beijing
  • Zhejiang University

Registry information

Official study title

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

Acronym: Act

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Nov 17, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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