Atherosclerosis Obliterans, Femoropopliteal Artery Occlusion, In-stent Restenosis, Lesion; Vascular
Conditions
Keywords
femoropopliteal Artery Occlusion, debulking, drug-coated balloon, bail-out stenting, endovascular therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICElesion preparation devices
successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty
DEVICEconventional balloon
Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure.
Sponsors
RenJi Hospital
Shanghai Zhongshan Hospital
Huashan Hospital
First Affiliated Hospital of Zhejiang University
Xuanwu Hospital, Beijing
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Second Affiliated Hospital of Soochow University
Qingdao Hiser Medical Group
Shanghai Pudong Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form * Patient has a score from 2 to 5 following Rutherford classification * Unilateral or bilateral F-P occlusive lesions (enrollment of one or both target limbs depend on operators) * Complete recanalization followed by POBA, Chocolate PTA, Scoring PTA, Shockwave PTA, SilverHawk, TurboHawk, Jetstream, Angiojet, Laser and Rotarex Angiographic Inclusion Criteria: * TASC II-Type A/B/C/D * Iliac inflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)-less than 50% residual stenosis * There is angiographic evidence of at least one-vessel-runoff (\>10cm) to the foot General
Exclusion criteria
* Projected for major amputation of target limb (above ankle joint) * Change to thrombectomy or bypass during operation * Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated * Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion * female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding. * Life expectancy of less than twelve months. * Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period. * Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (\> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days). * Patient unwilling or unlikely to comply with Follow-Up schedule Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from TLR | within 12 months post-procedure | Percentage of participants with a 1-year TLR free survival |
| Incidence of complications | immediately following procedure (day 30) | Procedure-related complications at day 30, defined as: procedure-related distal embolization, acute post-procedural target vessel thrombosis, bleeding, perforation, acute renal failure |
| Major adverse event | within 12 months post-procedure | Major adverse events (MAE) rate at 1 year, defined as: Myocardial Infarction (MI), major amputation, all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amputation Free Survival | within 12 months post-procedure | Percentage of participants with a 1-year amputation free survival |
| Numbers of patients with Primary patency | within 3, 6, 12 months post-procedure | 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 |
| Technical Success | within 24 hours post-procedure | Technical success, defined as the ability to cross the target lesion with the device, set up antegrade blood flow and leave residual stenosis \<30% |
| Improvement of related symptoms | within 3, 6, 12 months post-procedure | related symptoms could be identified as Rutherford classification from level 1-6. improvement in Rutherford classification compared to the pre-procedure Rutherford classification |
| Improvement of ABI | within 3, 6, 12 months post-procedure | Increase of Ankle-Brachial Index (ABI) at 12, 24 months, defined as: an increase in ABI compared to baseline |
| Incidence of dissection and types | immediately following vessel preparation | 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 |
| Incidence of Bailout stenting | immediately following vessel preparation and DCB angioplasty | Bailout stenting, defined as stent implantation after vessel preparation and DCB including bare metal stents (BMS), covered stents and drug-eluting stents (DES) |
Countries
China
Contacts
Primary ContactBo Yu, M.D.
Backup ContactWeihao Shi, M.D.
Outcome results
None listed