NCT03687983

Safety and Efficacy Study of GoldenFlow Peripheral Stent System

Safety and Efficacy Study of GoldenFlow Peripheral Stent System, A Prospective, Multi-center, Single-Arm Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lower limb artery stenosis or occlusion diseases.

Detailed description

A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lower limb artery stenosis or occlusion diseases. A total of 90 cases of patients, who are suitable to be treated with Peripheral Stent will be screened and enrolled according to the inclusion and exclusion criteria, and the lesion will be treated with GodenFlow Peripheral Stent System under the guidance of Digital Subtraction Angiography (DSA). Clinical and imaging follow-up was conducted 3 months and 6 months after surgery, The follow-ups mainly included clinical symptoms and signs, ankle-brachial index (ABI) and colour Doppler ultrasound, Computed Tomography Angiography (CTA), etc., for the sake of verifying the efficacy and safety of the device in treating patients with lower limb artery stenosis or occlusion.

Conditions

• Iliac Artery Stenosis
• Iliac Artery Occlusion
• Femoral Artery Stenosis
• Femoral Artery Occlusion
• Popliteal Arterial Stenosis
• Popliteal Artery Occlusion

Interventions

Type	Name	Description
DEVICE	GoldenFlow Peripheral Stent System	Performing anaesthetic and pathological angiography according to the standard method, and select appropriate stent specifications according to the contrast results. After 1:1 pre-expansion, the stent system will be imparted into the lesion location, the stent will be distally positioned and released. The Tip head will be reset and the conveyor will be removed. If necessary, local re-expansion can be carried out. Remove the catheter and suture the wound. Postoperative treatment and anticoagulation.

Timeline

• Start date: 2016-05-11
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2018-09-27
• Last updated: 2018-09-27

Locations

12 sites across 1 country: China