NCT05246410

A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.

A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Acotec Scientific Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.

Detailed description

The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.

Conditions

• Peripheral Vascular Disease (PVD)
• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
DEVICE	Spot stent system	Spot stent system designed and produced by Acotec
DEVICE	Self-expanding peripheral stent system	Self-expanding peripheral stent system designed and produced by Ev3, Inc

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-11-28
• Completion: 2024-12-30
• First posted: 2022-02-18
• Last updated: 2023-11-29

Locations

2 sites across 1 country: China