Peripheral Arterial Disease (PAD)
Conditions
Brief summary
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years old and ≤85 years old 2. Rutherford clinical category classification：2-5 3. Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery 4. At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography 5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Exclusion criteria
1. Aneurysms near target lesions or popliteal aneurysms. 2. The guide wire cannot pass smoothly through the target lesion. 3. Known allergy to contrast agents, heparin or paclitaxel. 4. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial. 5. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating. 6. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of device success | intraoperative |
| rate of procedural success | intraoperative |
| rate of technical success | intraoperative |
| rate of primary patency of target lesion | 12 months |
| rate of Clinically-driven TLR | 12 months |
| rate of TLR | 1 month |
| rate of Clinically-driven TVR | 12 months |
| rate of TVR | 1 month |
| change in Rutherford clinical category (target limb) | 12 months |
| change in ankle brachial index(ABI) | 12 months |
| rate of SAE | 12 months |
| rate of All-cause mortality | 1 month |
| rate of Major amputation | 1 month |
| rate of target lesion thrombosis | 12 months |
| Rate of adverse events | intraoperative |
Countries
China
Contacts
Primary ContactJie Liang
Outcome results
None listed