NCT06539689

A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries

A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: FrontAce Scientific Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.

Conditions

• Peripheral Arterial Disease
• Stenosis
• Dissection

Interventions

Type	Name	Description
DEVICE	Sperstent® peripheral spot stent system	Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
DEVICE	Everflex® self-expanding peripheral stent system	Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-12-04
• Completion: 2026-12-31
• First posted: 2024-08-06
• Last updated: 2024-08-06

Locations

12 sites across 1 country: China