NCT05473884

Lesion Preparation in Femoropopliteal Artery Occlusion Disease

CIVILIAN Study in Femoropopliteal Artery Occlusion Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Shanghai Pudong Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	lesion preparation devices	successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty
DEVICE	conventional balloon	Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2022-07-26
• Last updated: 2022-11-07

Locations

1 site across 1 country: China