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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05498740
Other study ID # 04202106
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 4, 2022
Est. completion date December 2024

Study information

Verified date August 2022
Source Zhejiang Zylox Medical Device Co., Ltd.
Contact Jie Liang
Phone 13819565660
Email jie.liang@zyloxmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Age =18 years old and =85 years old 2. Rutherford clinical category classification:2-5 3. Significant stenosis (=50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery 4. At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography 5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments. Exclusion Criteria: 1. Aneurysms near target lesions or popliteal aneurysms. 2. The guide wire cannot pass smoothly through the target lesion. 3. Known allergy to contrast agents, heparin or paclitaxel. 4. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial. 5. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating. 6. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Drug eluting Balloon
Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.

Locations

Country Name City State
China Xuanwu hospital Beijing
China Affiliated Hospital of Chengde Medical College Chengde
China The Third People's Hospital of Chengdu Chengdu
China The First Affiliated Hospital of Dalian Medical University Dalian
China The Second Affiliated Hospital of Dalian Medical University Dalian
China Guangzhou Huaqiao hospital Guangzhou
China Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University Guangzhou
China The Third Affiliated Hospital of Guangzhou Medical University Guangzhou
China The First Affiliated Hospital of Harbin Medical University Ha'erbin
China Hangzhou First People's Hospital Hangzhou
China First Hospital of Lanzhou University Lanzhou
China Ningbo huamei hospital Ningbo
China Qingdao Municipal Hospital Qingdao
China Ruian People's Hospital Rui'an
China Shanghai Ninth People'S Hospital Shanghai
China Zhongshan Hospital Shanghai
China Northern Theatre General Hospital Shenyang
China Tianjin Medical University General Hospital Tianjin
China Tianjin People's Hospital Tianjin
China Weifang People's Hospital Weifang
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou
China The Second Affiliated Hospital of Wenzhou Medical University Wenzhou
China The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine Xi'an
China People's Hospital of Xinjiang Uygur Autonomous Region Xinjiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of device success intraoperative
Primary rate of procedural success intraoperative
Primary rate of technical success intraoperative
Primary rate of primary patency of target lesion 12 months
Primary rate of primary patency of target lesion 24 months
Primary rate of Clinically-driven TLR 12 months
Primary rate of Clinically-driven TLR 24 months
Primary rate of TLR 1 month
Primary rate of TLR 12 months
Primary rate of TLR 24 months
Primary rate of Clinically-driven TVR 12 months
Primary rate of Clinically-driven TVR 24 months
Primary rate of TVR 1 month
Primary rate of TVR 12 months
Primary rate of TVR 24 months
Primary change in Rutherford clinical category (target limb) 12 months
Primary change in Rutherford clinical category (target limb) 24 months
Primary change in ankle brachial index(ABI) 12 months
Primary change in ankle brachial index(ABI) 24 months
Primary rate of SAE 12 months
Primary rate of SAE 24 months
Primary rate of All-cause mortality 1 month
Primary rate of All-cause mortality 12 months
Primary rate of All-cause mortality 24 months
Primary rate of Major amputation 1 month
Primary rate of Major amputation 12 months
Primary rate of Major amputation 24 months
Primary rate of target lesion thrombosis 12 months
Primary rate of target lesion thrombosis 24 months
Primary Rate of adverse events intraoperative
Primary Rate of adverse events 1 month
Primary Rate of adverse events 12 months
Primary Rate of adverse events 24 months
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