Lesion Preparation in Femoropopliteal Artery Occlusion Disease (CIVILIAN)

Shanghai Pudong Hospital

Status: Enrolling

Conditions: Atherosclerosis Obliterans; Lesion; Vascular; Femoropopliteal Artery Occlusion; In-stent Restenosis

Treatments: Device: lesion preparation devices; Device: conventional balloon

Study type: Observational

Funder types: Other

Identifiers

NCT05473884

Shanghai-CIVILIAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 Exclusion Criteria:

• Testified for acute F-P arterial embolization
• Thromboangiitis obliterans
• Failed for recanalization

Trial design

800 participants in 2 patient groups

lesion preparation with POBA in femoropopliteal Artery occlusion

Description:

Patients with femoropopliteal artery occlusion were treated by plain old balloon angioplasty followed with DCB.

Treatment:

Device: conventional balloon

lesion preparation with debulking devices in femoropopliteal Artery occlusion

Description:

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.

Treatment:

Device: lesion preparation devices