Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
- Conditions
- Peripheral Arterial Disease (PAD)
- Interventions
- Device: Drug eluting Balloon
- Registration Number
- NCT05498740
- Lead Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description drug eluting balloon catheter Drug eluting Balloon use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
- Primary Outcome Measures
Name Time Method rate of device success intraoperative rate of technical success intraoperative rate of Clinically-driven TVR 24 months change in Rutherford clinical category (target limb) 24 months rate of primary patency of target lesion 24 months rate of TLR 24 months rate of Clinically-driven TLR 24 months rate of procedural success intraoperative rate of TVR 24 months rate of SAE 24 months rate of Major amputation 24 months change in ankle brachial index(ABI) 24 months rate of All-cause mortality 24 months rate of target lesion thrombosis 24 months Rate of adverse events 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Ningbo huamei hospital
🇨🇳Ningbo, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Affiliated Hospital of Chengde Medical College
🇨🇳Chengde, China
The Third People's Hospital of Chengdu
🇨🇳Chengdu, China
Xuanwu hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, China
The Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
Guangzhou Huaqiao hospital
🇨🇳Guangzhou, China
Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University
🇨🇳Guangzhou, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, China
First Hospital of Lanzhou University
🇨🇳Lanzhou, China
Qingdao Municipal Hospital
🇨🇳Qingdao, China
Ruian People's Hospital
🇨🇳Rui'an, China
Zhongshan Hospital
🇨🇳Shanghai, China
Northern Theatre General Hospital
🇨🇳Shenyang, China
Shanghai Ninth People'S Hospital
🇨🇳Shanghai, China
Weifang People's Hospital
🇨🇳Weifang, China
Tianjin People's Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
🇨🇳Xi'an, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Xinjiang, China