Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia

Study Overview
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Brief Summary
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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).

Official Title
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Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia

Conditions
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Peripheral Arterial Disease (PAD)

Intervention / Treatment
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* Device: Drug eluting Balloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug eluting balloon catheter<br>use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery | Device: Drug eluting Balloon<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 primary patency of target lesion |  | 24 months | 
| rate of Clinically-driven TLR |  | 12 months | 
| rate of Clinically-driven TLR |  | 24 months | 
| rate of TLR |  | 1 month | 
| rate of TLR |  | 12 months | 
| rate of TLR |  | 24 months | 
| rate of Clinically-driven TVR |  | 12 months | 
| rate of Clinically-driven TVR |  | 24 months | 
| rate of TVR |  | 1 month | 
| rate of TVR |  | 12 months | 
| rate of TVR |  | 24 months | 
| change in Rutherford clinical category (target limb) |  | 12 months | 
| change in Rutherford clinical category (target limb) |  | 24 months | 
| change in ankle brachial index(ABI) |  | 12 months | 
| change in ankle brachial index(ABI) |  | 24 months | 
| rate of SAE |  | 12 months | 
| rate of SAE |  | 24 months | 
| rate of All-cause mortality |  | 1 month | 
| rate of All-cause mortality |  | 12 months | 
| rate of All-cause mortality |  | 24 months | 
| rate of Major amputation |  | 1 month | 
| rate of Major amputation |  | 12 months | 
| rate of Major amputation |  | 24 months | 
| rate of target lesion thrombosis |  | 12 months | 
| rate of target lesion thrombosis |  | 24 months | 
| Rate of adverse events |  | intraoperative | 
| Rate of adverse events |  | 1 month | 
| Rate of adverse events |  | 12 months | 
| Rate of adverse events |  | 24 months |