NCT05759819

Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease

An Exploratory Study to Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Occlusive Arterial Disease

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Otsuka Medical Devices Co., Ltd. Japan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery

Detailed description

This Study demonstrate an exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Standard stenting	The cilostazol-coated BioMimics 3D stent on the delivery system is deployed into the target lesion.

Timeline

• Start date: 2023-03-10
• Primary completion: 2024-12-05
• Completion: 2026-12-31
• First posted: 2023-03-08
• Last updated: 2025-02-07

Locations

5 sites across 1 country: Japan