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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05415995
Other study ID # V1.1/2021-12-25
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date December 2024

Study information

Verified date March 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

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.


Description:

This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 202
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Age 18-85 years; - =70% diameter stenosis or occlusion in the target below-the-knee lesion; - Rutherford Category 3-6; - Subjects are willing to sign informed consent; Exclusion Criteria: - Planned major limb amputation within 30 days after the procedure; - In-stent stenosis in the target lesion; - Severely calcified target lesions; - Creatinine>2.5mg/dL; - History of allergies to anesthetics, contrast agents; - Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint; - Other circumstances judged by researchers that are not suitable for enrollment.

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 China-Japan Friendship Hospital Beijing
China Peking University First Hospital Beijing
China The First Affiliated Hospital Of Dalian Medical University Dalian Liaoning
China Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine Hangzhou Zhejiang
China The second hospital of Anhui Medical university Hefei Anhui
China The affiliated hospital of southwest medical university Luzhou Sichuan
China Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school Nanjing Jiangsu
China Huamei hospital, University of Chinese academy of sciences Ningbo Zhejiang
China The affiliated Hospital of QingDao University Qingdao Shandong
China Changhai Hospital Shanghai
China Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine Shanghai
China General Hospital of Northern Theater Command Shenyang Liaoning
China Hebei General Hospital Shijiazhuang Hebei
China The First Hospital of Hebei Medical University Shijiazhuang Hebei
China Shanxi Bethune Hospital Taiyuan Shanxi
China Tianjin Medical University General Hospital Tianjin Tianjin
China The central hospital of Wuhan Wuhan Hubei
China Zhongshan Hospital Xiamen University Xiamen Fujian
China HeNan Province People's Hospital Zhengzhou Henan
China The First Affiliated Hospital Of Zhengzhou University Zhengzhou Henan

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
Other Change of Ankle-Branchial Index(ABI) ABI is a simple measurement identifies unrecognized Peripheral Arterial Disease. 180 days
Other The rate of target lesion revascularization(TLR) TLR is defined as revascularization of the target lesion with stenosis =70%. 30 days/ 180 days
Primary Rate of primary patency of the target lesion Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation. 180 days
Secondary Success rate of the device Success rate of the device is defined as a situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn. Intraoperation
Secondary Success rate of the technique On the basis of device success,technique success rate is defined as restored blood flow in the lesion after the treatment, and the residual stenosis =30%. Immediately after the intervention
Secondary Success rate of the operation On the basis of technique success, operation success is defined as no adverse event happening. Within 7 days
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