Clinical trial NCT05620095: Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
Official title: Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arteriosclerosis
Peripheral Artery Disease
Chronic Limb Threatening Ischemia
Keywords: Drug-coated Balloon
Angioplasty
Below the knee
Lead sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: RenJi Hospital
name: Zhejiang University
name: First People's Hospital of Hangzhou
name: Second Affiliated Hospital of Suzhou University
name: Qingdao University
name: Chengdu University of Traditional Chinese Medicine
name: Shanghai Zhongshan Hospital
name: Huashan Hospital
First posted: 2022-11-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffered with Chronic Limb Theratening Ischemia and with significant infrapopliteal artery lesions.

Brief 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).

Detailed description: Patients with critical limb ischemia (Rutherford category 4-5) 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.

Eligibility criteria: Inclusion Criteria:

1. Rutherford grade 4-5.
2. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
3. 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.
4. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow.
5. At least one of the infrapopliteal arteries received a drug-coated balloon.
6. 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%.
7. 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.
8. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
9. Life expectancy\> 24 months.

Exclusion Criteria:

1. Blood flow was not successfully reestablished.
2. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
3. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
4. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
5. Pregnant and lactating women.
6. Patients with Berg's disease.
7. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia

Primary outcomes:
measure: Primary sustained clinical improvement at 12 months post-procedure
timeFrame: 12 months
measure: Freedom of major limb adverse events at 12 months post-procedure
timeFrame: 12 months
Secondary outcomes:
measure: Patency of the target lesions at 1 month, 3 months, 6 months and 12 months post-interventional
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Procedural success rate
timeFrame: 72 hours
measure: Vascular quality of life questionnaire(VascuQol)
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Wound healing rate
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at 1 month, 3 months, 6 months, 12 months post-procedure.
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Major adverse events at 1 month, 3 months, 6 months, 12 months post-procedure.
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Amputation free survival rate
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Primary sustained clinical improvement
timeFrame: 1 month, 3 months, 6 months
measure: Secondary sustained clinical improvement
timeFrame: 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Wuhan
country: China
facility: Zibo Feng
state: Hubei
city: Suzhou
country: China
facility: the second Affiliated Hospital of Medical College of Suzhou University
state: Jiangsu
city: Qingdao
country: China
facility: Qingdao Haici hospital affiliated to Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital of Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First People's hospital of Medical College of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: the First Affiliated hospital of Medicine College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Zibo Feng
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital, Beijing
name: Lianrui Guo
role: PRINCIPAL_INVESTIGATOR
References: