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

Zhejiang Zylox Medical Device

Status: Enrolling

Conditions: Peripheral Artery Disease

Treatments: Device: Drug eluting Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT05415995

V1.1/2021-12-25

Details and patient eligibility

About

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

Full 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 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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group

Experimental group

Description:

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.

Treatment:

Device: Drug eluting Balloon

101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group

Active Comparator group

Description:

Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.

Treatment:

Device: Drug eluting Balloon