Lesion Preparation in Femoropopliteal Artery Occlusion Disease

Shanghai Pudong Hospital800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Femoropopliteal Artery Occlusion Atherosclerosis Obliterans

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Testified for acute F-P arterial embolization * Thromboangiitis obliterans * Failed for recanalization

Outcomes

Primary Outcomes

Freedom from TLR

Percentage of participants with a 1-year TLR free survival

Time frame: 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

Time frame: 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

Time frame: within 12 months post-procedure

Secondary Outcomes

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%

Time frame: within 24 hours post-procedure

Incidence of dissection and types

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

Time frame: 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)

Time frame: immediately following vessel preparation and DCB angioplasty

Amputation Free Survival

Percentage of participants with a 1-year amputation free survival

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: within 3, 6, 12 months post-procedure

Lesion Preparation in Femoropopliteal Artery Occlusion Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts