Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

Peripheral Artery Disease Clinical Trial

— Act  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620095
• Other study ID #: the Act study
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2024
• Source: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Contact: Zibo Feng
• Phone: 86-13545160302
• Email: fengzibo[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Chronic Limb Threatening Ischemia
• Chronic Limb-Threatening Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	Hangzhou First People's hospital of Medical College of Zhejiang University	Hangzhou	Zhejiang
China	the First Affiliated hospital of Medicine College of Zhejiang University	Hangzhou	Zhejiang
China	Qingdao Haici hospital affiliated to Qingdao University	Qingdao	Shandong
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Renji Hospital of Shanghai Jiaotong University	Shanghai	Shanghai
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	the second Affiliated Hospital of Medical College of Suzhou University	Suzhou	Jiangsu
China	Zibo Feng	Wuhan	Hubei

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months
Secondary	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).	1 month, 3 months, 6 months, 12 months
Secondary	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.	72 hours
Secondary	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	1 month, 3 months, 6 months, 12 months
Secondary	Wound healing rate	Wound healing in patients with Rutherford grade 5.	1 month, 3 months, 6 months, 12 months
Secondary	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.	1 month, 3 months, 6 months, 12 months
Secondary	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.	1 month, 3 months, 6 months, 12 months
Secondary	Amputation free survival rate	Amputation free survival rate after surgery.	1 month, 3 months, 6 months, 12 months
Secondary	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.	1 month, 3 months, 6 months
Secondary	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.	1 month, 3 months, 6 months, 12 months