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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Huashan Hospital | OTHER |
| First Affiliated Hospital of Zhejiang University |
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Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.
Femoropopliteal artery occlusive disease is a common type of peripheral arterial disease (PAD). Hitherto, endovascular treatment has been testified and advocated as the first-line treatment of femoropopliteal occlusive disease. However, the in-stent restenosis has been a major limitation of well long-term patency rate in this segment due to physiological and geometrical issues. The concept "leave nothing behind" is proposed, and some vessel preparation methods and devices, such as directional atherectomy, rotational atherectomy, laser atherectomy are developed. This is a national, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions. A total of 1000 patients will be included in approximately 8 sites. The study is designed to demonstrate the inferiority of different vessel preparation strategies in various fields under long-term follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lesion preparation with POBA in femoropopliteal Artery occlusion | Patients with femoropopliteal artery occlusion were treated by plain old balloon angioplasty followed with DCB. |
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| lesion preparation with debulking devices in femoropopliteal Artery occlusion | Patients with femoropopliteal artery occlusion were treated by other lesion preparation devices, like Chocolate balloon, Shockwave balloon, TurboHawk, Jetstream and Rotarex and then followed by DCB. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lesion preparation devices | Device | successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from TLR | Percentage of participants with a 1-year TLR free survival | within 12 months post-procedure |
| Incidence of complications | Procedure-related complications at day 30, defined as: procedure-related distal embolization, acute post-procedural target vessel thrombosis, bleeding, perforation, acute renal failure | immediately following procedure (day 30) |
| Major adverse event | Major adverse events (MAE) rate at 1 year, defined as: Myocardial Infarction (MI), major amputation, all-cause mortality | within 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Technical success, defined as the ability to cross the target lesion with the device, set up antegrade blood flow and leave residual stenosis <30% | within 24 hours post-procedure |
| Incidence of dissection and types |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
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Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Yu, M.D. | Contact | 18918922698 | paul.yubo@gmail.com | |
| Weihao Shi, M.D. | Contact | 13601982603 | vascular741021@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pudong Hospital | Recruiting | Shanghai | Shanghai Municipality | 201200 | China |
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| OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Qingdao Hiser Medical Group | OTHER |
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| conventional balloon | Device | Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure. |
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Dissection patterns according to the National Heart, Lung and Blood Institute classification system for the coronary artery. (Type A-F) (A) Type A has minor radiolucent areas, (B) type B is a linear dissection, (C) type C has contrast outside the lumen, (D) type D is a spiral dissection, (E) type E has persistent filling defects, and (F) type F is a total occlusion without distal antegrade flow
| immediately following vessel preparation |
| Incidence of Bailout stenting | Bailout stenting, defined as stent implantation after vessel preparation and DCB including bare metal stents (BMS), covered stents and drug-eluting stents (DES) | immediately following vessel preparation and DCB angioplasty |
| Amputation Free Survival | Percentage of participants with a 1-year amputation free survival | within 12 months post-procedure |
| Numbers of patients with Primary patency | Primary patency rate at 6, 12, 24 months as determined by Duplex ultrasound at six months, defined as a target vessel with <50% diameter stenosis (systolic velocity ratio no greater than 2.4), without occurrence of target lesion revascularization between the index procedure and follow-up control | within 3, 6, 12 months post-procedure |
| Improvement of ABI | Increase of Ankle-Brachial Index (ABI) at 12, 24 months, defined as: an increase in ABI compared to baseline | within 3, 6, 12 months post-procedure |
| Improvement of related symptoms | related symptoms could be identified as Rutherford classification from level 1-6. improvement in Rutherford classification compared to the pre-procedure Rutherford classification | within 3, 6, 12 months post-procedure |