Durg Coated Balloon Angioplasty in Infrapopliteal Lesions (Act)

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).

Study Overview

• Status: Recruiting
• Conditions: Arteriosclerosis; Peripheral Artery Disease; Chronic Limb Threatening Ischemia
• Intervention / Treatment: Device: drug-coated balloon

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Zibo Feng; Phone Number: 86-13545160302; Email: fengzibo@hust.edu.cn
• Study Contact Backup: Name: Ye Du; Phone Number: 86-15827105515; Email: duye@hust.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Lianrui Guo
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Zibo Feng
      • Contact: Zibo Feng; Phone Number: 86-13545160302; Email: fengzibo@hust.edu.cn
      • Contact: Ye Du; Phone Number: 86-15827105515; Email: duye@hust.edu.cn
      • Sub-Investigator: Youpeng Zhu
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • the second Affiliated Hospital of Medical College of Suzhou University
      • Contact: Hongfei Sang
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • Qingdao Haici hospital affiliated to Qingdao University
      • Contact: Qiang Li
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Huashan Hospital, Fudan University
      • Contact: Weihao Shi
    • Shanghai, Shanghai, China
      • Recruiting
      • Renji Hospital of Shanghai Jiaotong University
      • Contact: Meng Ye
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital of Fudan University
      • Contact: Zhenyu Shi
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Hospital of Chengdu University of Traditional Chinese Medicine
      • Contact: Chunshui He
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Hangzhou First People's hospital of Medical College of Zhejiang University
      • Contact: Xin Fang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • the First Affiliated hospital of Medicine College of Zhejiang University
      • Contact: Ziheng Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients suffered with Chronic Limb Theratening Ischemia and with significant infrapopliteal artery lesions.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Wound healing rate	Wound healing in patients with Rutherford grade 5.	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.	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.	1 month, 3 months, 6 months, 12 months
Amputation free survival rate	Amputation free survival rate after surgery.	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.	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.	1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Collaborators: First People's Hospital of Hangzhou; Shanghai Zhongshan Hospital; RenJi Hospital; Huashan Hospital; Chengdu University of Traditional Chinese Medicine; Qingdao University; Xuanwu Hospital, Beijing; Zhejiang University; Second Affiliated Hospital of Suzhou University
• Investigators: Principal Investigator: Lianrui Guo, Xuanwu Hospital, Beijing; Principal Investigator: Zibo Feng, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Drug-coated Balloon; Angioplasty; Below the knee
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Ischemia; Peripheral Arterial Disease; Arteriosclerosis; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: the Act study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No