Overview
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).
Eligibility
Inclusion Criteria:
- Age ≥18 years old and ≤85 years old
- Rutherford clinical category classification:2-5
- Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
- At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
- 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:
- Aneurysms near target lesions or popliteal aneurysms.
- The guide wire cannot pass smoothly through the target lesion.
- Known allergy to contrast agents, heparin or paclitaxel.
- 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.
- Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
- Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.