Lesion Preparation in Femoropopliteal Artery Occlusion Disease

Recruiting

• Conditions: Atherosclerosis Obliterans; Lesion; Vascular; Femoropopliteal Artery Occlusion; In-stent Restenosis
• Interventions: Device: conventional balloon; Device: lesion preparation devices

• Registration Number: NCT05473884
• Lead Sponsor: Shanghai Pudong Hospital

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lesion preparation with POBA in femoropopliteal Artery occlusion	conventional balloon	Patients with femoropopliteal artery occlusion were treated by plain old balloon angioplasty followed with DCB.
lesion preparation with debulking devices in femoropopliteal Artery occlusion	lesion preparation devices	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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%
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)
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
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
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

Trial Locations

Locations (1)

Shanghai Pudong Hospital; 🇨🇳 Shanghai, Shanghai, China