NCT06735846

Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide Wire

Clinical Investigation to Evaluate the Safety and Performance of Demax Guide Wire

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: DemaxGroup · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to confirm the safety and performance of the Guide Wire when used in patients with peripheral vascular or coronary vascular disease for diagnostic or treatment procedures and will be the pivotal trial for this device. This study intends to evaluate the Guide Wire in its ability to successfully deploy an intended diagnostic or therapeutic catheter according to the IFU without any device related deficiencies, time to reach a specified position, and total number of insertion attempts to reach a primary performance endpoint.

Conditions

• Peripheral Vascular Diseases
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Guide wire	Insert the distal end of the guide wire into the introducer sheath and enter the blood vessel through the introducer sheath;5.Insert the catheter directly into the blood vessel through the guide wire, and when the catheter reaches the target position, exit the guide wire.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2024-12-16
• Last updated: 2024-12-16