A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Drug eluting Balloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group<br>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. | Device: Drug eluting Balloon<br>* 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.<br>|
| Active Comparator: 101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group<br>Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016. | Device: Drug eluting Balloon<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |