NCT06030271

A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Insight Lifetech Co., Ltd. · Industry
• Sex: All
• Age: 26 Years
• Healthy volunteers: Not accepted

Summary

The trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the TrueCross Single-use Microcatheter.

Detailed description

The objective of this clinical investigation is to evaluate the performance and safety of the TrueCross Single-use Microcatheter in patients requiring a PCI procedure as well as the related clinical benefits. The study will include 59 subjects suffering from coronary artery disease requiring a percutaneous coronary intervention. Enrollment duration will be 4 months or so without follow-up. It is a single-arm trial.In the uneventual case of a potential dropout (serious protocol deviation or procedure interruption unrelated to the catheter), subjects will be replaced to reach 59 evaluable subjects for the Per Protocol population.

Conditions

• Coronary Artery Disease Obliterative
• Chronic Total Occlusion (CTO)

Interventions

Type	Name	Description
DEVICE	Microcatheter	Support and facilitate the placement of the guidewire in the coronary artery with a CTO.

Timeline

• Start date: 2022-10-13
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2023-09-08
• Last updated: 2023-09-08

Locations

7 sites across 3 countries: Georgia, Greece, Singapore