A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

Peripheral Artery Disease Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415995
• Other study ID #: V1.1/2021-12-25
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

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