A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
- Conditions
- Peripheral Artery Disease
- Interventions
- Device: Drug eluting Balloon
- Registration Number
- NCT05415995
- Lead Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 202
- 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；
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group Drug eluting Balloon Patients in this group use Drug eluting Balloon (Zylox-tonbridge), this is the product to be test in this clinical trail. The drug we coated is paclitaxel. 101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group Drug eluting Balloon Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.
- Primary Outcome Measures
Name Time Method Rate of primary patency of the target lesion 180 days Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation.
- Secondary Outcome Measures
Name Time Method Success rate of the technique Immediately after the intervention 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%.
Success rate of the operation Within 7 days On the basis of technique success, operation success is defined as no adverse event happening.
Success rate of the device Intraoperation 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.
Trial Locations
- Locations (20)
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital Of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The second hospital of Anhui Medical university
🇨🇳Hefei, Anhui, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
Hebei General Hospital
🇨🇳Shijiazhuang, Hebei, China
HeNan Province People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital Of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The central hospital of Wuhan
🇨🇳Wuhan, Hubei, China
Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school
🇨🇳Nanjing, Jiangsu, China
The affiliated Hospital of QingDao University
🇨🇳Qingdao, Shandong, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
General Hospital of Northern Theater Command
🇨🇳Shenyang, Liaoning, China
The affiliated hospital of southwest medical university
🇨🇳Luzhou, Sichuan, China
Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine
🇨🇳Hangzhou, Zhejiang, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
Huamei hospital, University of Chinese academy of sciences
🇨🇳Ningbo, Zhejiang, China
Changhai Hospital
🇨🇳Shanghai, China
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
🇨🇳Shanghai, China
Peking University First Hospital
🇨🇳Beijing, China