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NOT YET RECRUITING
NCT06735846
NA

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

Sponsor: DemaxGroup

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-03

Completion Date

2025-07

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

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.