ArteriosclerosisActNCT05620095
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
An observational study of Arteriosclerosis and Peripheral Artery Disease, run by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology at 10 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriosclerosis, Peripheral Artery Disease, Chronic Limb Threatening Ischemia
- What is being tested?
- drug-coated balloon
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 10 sitesChina
- Study dates
- 1 Dec 2020to 1 Nov 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffered with Chronic Limb Theratening Ischemia and with significant infrapopliteal artery lesions.
Who may be able to join
- 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%.
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- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Lianrui Guo
- Recruiting
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan
Chunshui He
- Recruiting
Hangzhou First People's hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang
Xin Fang
- Recruiting
the First Affiliated hospital of Medicine College of Zhejiang University
Hangzhou, Zhejiang
Ziheng Wu
- Recruiting
Qingdao Haici hospital affiliated to Qingdao University
Qingdao, Shandong
Qiang Li
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
Weihao Shi
- Recruiting
Renji Hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Meng Ye
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality
Zhenyu Shi
- Recruiting
the second Affiliated Hospital of Medical College of Suzhou University
Suzhou, Jiangsu
Hongfei Sang
- Recruiting
Zibo Feng
Wuhan, Hubei, 430000
Zibo Feng, 86-13545160302, fengzibo@hust.edu.cn
Ye Du, 86-15827105515, duye@hust.edu.cn
About this study
Official title: Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)
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).
Read the 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.
- Being tested
- drug-coated balloon
- Keywords
- Drug-coated Balloon, Angioplasty, Below the knee
- Medical subject headings
- Arteriosclerosis, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-coated balloonDevice
To evaluate the effectiveness and safety of drug-coated balloon angioplasty for infrapopliteal artery lesions in patients with CLTI.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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
Measured: 1 month, 3 months, 6 months, 12 months
Wound healing rate
Wound healing in patients with Rutherford grade 5.
Measured: 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.
Measured: 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.
Measured: 1 month, 3 months, 6 months, 12 months
Amputation free survival rate
Amputation free survival rate after surgery.
Measured: 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.
Measured: 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.
Measured: 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Dec 2020
- Primary completion1 Nov 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, RenJi Hospital, Zhejiang University, First People's Hospital of Hangzhou, Second Affiliated Hospital of Suzhou University, Qingdao University, Chengdu University of Traditional Chinese Medicine, Shanghai Zhongshan Hospital, Huashan Hospital
- Responsible party
- Principal investigator, Zibo Feng, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Zibo Feng, Principal investigator, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyLianrui Guo, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620095
- Sponsor's protocol ID
- the Act study
- Acronym
- Act
- Status last verified
- Jan 2026
- First submitted
- 9 Nov 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No