Peripheral Artery Disease
Conditions
Keywords
Drug eluting balloon catheter, Peripheral Artery Disease
Brief summary
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
Interventions
DEVICESirolimus-eluting balloon catheter
Sirolimus-eluting balloon catheter designed and produced by Acotec
Paclitaxel-eluting balloon catheter (trade name:DHALIA)
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old and ≤80 years old * Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5 * SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion. * The length of target lesion less than 20 cm * Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed
Exclusion criteria
* The plasma creatinine level is higher than 150 umol/L * Thrombolysis or thrombectomy is required * There are more than 2 lesion need to treat in the target vessel. * The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks. * The target lesion had residual stenosis\>30% or flow-limit dissection after pre-dilatation. * The patient had outflow less than 1 vessel * The lesion located in a stent. * Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated. * Women who are pregnant or breast-feeding. * The subjects have participated in other drug property studies or device studies that have not yet completed the main end point. * Patient has life expectancy of less than 12 months. * The investigator think the patient is not suitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary patency rate of target lesion at 12 months post-procedure | 12 months post-procedure | Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Rutherford class from baseline | 12 months post-procedure | Defined as change in target limb Rutherford class from baseline to 12 months |
| The change of ankle-brachial index (ABI) from baseline | 12 months post-procedure | Defined as change of target limb ABI from baseline to 12 months |
| Rate of device success | immediate post-procedure | Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP) |
| Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure | 12 months post-procedure | Defined as any reintervention at the target lesion due to symptoms or the following index: drop of ABI \>20% or ABI \>0.15 compared to the post-procedure ABI during 12 months post-procedure |
| Rate of composite safety endpoint | 30 days post-procedure | Defined a composite rate of device-related or procedure-related death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) or target lesion thrombotic events through 30 days post- procedure |
Countries
China
Contacts
Primary ContactGuo Wei, MD
Outcome results
None listed