Peripheral Artery Disease
Conditions
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 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.
Interventions
DEVICEDrug eluting Balloon
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.
Sponsors
Zhejiang Zylox Medical Device Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of primary patency of the target lesion | 180 days | Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of the device | Intraoperation | 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situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn. |
| Success rate of the technique | Immediately after the intervention | 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%. |
| Success rate of the operation | Within 7 days | On the basis of technique success, operation success is defined as no adverse event happening. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of Ankle-Branchial Index(ABI) | 180 days | ABI is a simple measurement identifies unrecognized Peripheral Arterial Disease. |
| The rate of target lesion revascularization(TLR) | 30 days/ 180 days | TLR is defined as revascularization of the target lesion with stenosis ≥70%. |
Countries
China
Contacts
Primary ContactJie Liang
Outcome results
None listed