Status:
UNKNOWN
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
Lead Sponsor:
Zhejiang Zylox Medical Device Co., Ltd.
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
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 safe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT05415995
Start Date
March 1 2022
End Date
December 1 2024
Last Update
June 13 2022
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
The second hospital of Anhui Medical university
Hefei, Anhui, China
2
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
3
Hebei General Hospital
Shijiazhuang, Hebei, China
4
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China