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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
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.
The second hospital of Anhui Medical university
Hefei, Anhui, China
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.
Time frame: 180 days
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situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn.
Time frame: Intraoperation
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%.
Time frame: Immediately after the intervention
Success rate of the operation
On the basis of technique success, operation success is defined as no adverse event happening.
Time frame: Within 7 days
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