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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Rutherford grade 4-5.

• 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.

Locations
Other Locations
China
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Hospital of Chengdu University of Traditional Chinese Medicine
RECRUITING
Chengdu
Hangzhou First People's hospital of Medical College of Zhejiang University
RECRUITING
Hangzhou
the First Affiliated hospital of Medicine College of Zhejiang University
RECRUITING
Hangzhou
Qingdao Haici hospital affiliated to Qingdao University
RECRUITING
Qingdao
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Renji Hospital of Shanghai Jiaotong University
RECRUITING
Shanghai
Zhongshan Hospital of Fudan University
RECRUITING
Shanghai
the second Affiliated Hospital of Medical College of Suzhou University
RECRUITING
Suzhou
Zibo Feng
RECRUITING
Wuhan
Contact Information
Primary
Zibo Feng
fengzibo@hust.edu.cn
86-13545160302
Backup
Ye Du
duye@hust.edu.cn
86-15827105515
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 1000
Sponsors
Leads: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Collaborators: RenJi Hospital, Zhejiang University, Xuanwu Hospital, Beijing, Qingdao University, First People's Hospital of Hangzhou, Huashan Hospital, Shanghai Zhongshan Hospital, Chengdu University of Traditional Chinese Medicine, Second Affiliated Hospital of Suzhou University

This content was sourced from clinicaltrials.gov