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This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group | Experimental | 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 | Active Comparator | Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting Balloon | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn.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 |
| Success rate of the technique |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Ankle-Branchial Index(ABI) | ABI is a simple measurement identifies unrecognized Peripheral Arterial Disease. | 180 days |
| The rate of target lesion revascularization(TLR) | TLR is defined as revascularization of the target lesion with stenosis ≥70%. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Liang | Contact | 13819565660 | jie.liang@zyloxmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Junmin Bao | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second hospital of Anhui Medical university | Not yet recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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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 |
| Success rate of the operation | On the basis of technique success, operation success is defined as no adverse event happening. | Within 7 days |
| 30 days/ 180 days |
| Zhongshan Hospital Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| Hebei General Hospital | Not yet recruiting | Shijiazhuang | Hebei | China |
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| The First Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| HeNan Province People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| The First Affiliated Hospital Of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
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| The central hospital of Wuhan | Not yet recruiting | Wuhan | Hubei | China |
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| Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school | Not yet recruiting | Nanjing | Jiangsu | China |
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| The First Affiliated Hospital Of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | China |
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| General Hospital of Northern Theater Command | Not yet recruiting | Shenyang | Liaoning | China |
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| The affiliated Hospital of QingDao University | Not yet recruiting | Qingdao | Shandong | China |
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| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
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| The affiliated hospital of southwest medical university | Not yet recruiting | Luzhou | Sichuan | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Huamei hospital, University of Chinese academy of sciences | Not yet recruiting | Ningbo | Zhejiang | China |
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| China-Japan Friendship Hospital | Not yet recruiting | Beijing | China |
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| Peking University First Hospital | Not yet recruiting | Beijing | China |
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| Changhai Hospital | Recruiting | Shanghai | China |
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| Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine | Not yet recruiting | Shanghai | China |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |