Clinical trial NCT05415995: A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
Official title: A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of primary patency of the target lesion
timeFrame: 180 days
Secondary outcomes:
measure: Success rate of the device
timeFrame: Intraoperation
measure: Success rate of the technique
timeFrame: Immediately after the intervention
measure: Success rate of the operation
timeFrame: Within 7 days
Other outcomes:
measure: Change of Ankle-Branchial Index(ABI)
timeFrame: 180 days
measure: The rate of target lesion revascularization(TLR)
timeFrame: 30 days/ 180 days
Locations:
city: Hefei
country: China
facility: The second hospital of Anhui Medical university
state: Anhui
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: HeNan Province People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital Of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: The central hospital of Wuhan
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school
state: Jiangsu
city: Dalian
country: China
facility: The First Affiliated Hospital Of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Qingdao
country: China
facility: The affiliated Hospital of QingDao University
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Luzhou
country: China
facility: The affiliated hospital of southwest medical university
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine
state: Zhejiang
city: Ningbo
country: China
facility: Huamei hospital, University of Chinese academy of sciences
state: Zhejiang
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
Study officials:
affiliation: Changhai Hospital
name: Junmin Bao
role: PRINCIPAL_INVESTIGATOR
References: