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
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Zylox Medical Device Co., Ltd. |
China,
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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