Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

NCT05620095 | Recruiting

• 1 other identifier: the Act study
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 10

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).

Conditions

Arteriosclerosis; Chronic Limb Threatening Ischemia; Peripheral Artery Disease

Keywords

Drug-coated Balloon; Angioplasty; Below the knee

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Patency of the target lesions at 1 month, 3 months, 6 months and 12 months post-interventional

  1 month, 3 months, 6 months, 12 months

• Procedural success rate

  72 hours

• Vascular quality of life questionnaire(VascuQol)

  1 month, 3 months, 6 months, 12 months

• Wound healing rate

  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.

  1 month, 3 months, 6 months, 12 months

Interventions

drug-coated balloon DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: collaborator
• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology: lead
• RenJi Hospital: collaborator
• Zhejiang University: collaborator
• First People's Hospital of Hangzhou: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• Qingdao University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (10)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Zibo Feng

Wuhan, Hubei, 430000, China

RECRUITING

the second Affiliated Hospital of Medical College of Suzhou University

Suzhou, Jiangsu, China

RECRUITING

Qingdao Haici hospital affiliated to Qingdao University

Qingdao, Shandong, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Renji Hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

RECRUITING

Hangzhou First People's hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

the First Affiliated hospital of Medicine College of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Arteriosclerosis; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Zibo Feng

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

  PRINCIPAL INVESTIGATOR

• Lianrui Guo

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zibo Feng

CONTACT

86-13545160302; fengzibo@hust.edu.cn

Ye Du

CONTACT

86-15827105515; duye@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vascular Surgery, Liyuan Hospital

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: December 1, 2020
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)